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NCT Number: NCT07322458

The Effect of Spinal Cord Stimulation on Orthostatic Hypotension in Parkinsonism and Its Related Mechanisms

Parkinson's disease (PDS) is a syndrome characterized by tremor, bradykinesia, rigidity, and postural disturbances. Causes include Parkinson's disease (PD), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). Non-motor symptoms of PDS, such as neurogenic orthostatic hypotension (nOH), have received more intensive research due to their greater disabling potential compared to motor symptoms. In patients with PD and MSA, nOH can lead to intolerance to medications such as levodopa, significantly increasing the risk of falls, accelerating cognitive decline, and increasing the risk of all-cause mortality. However, conventional pharmacological treatments (such as midodrine, droxidopa, and fludrocortisone) and non-pharmacological approaches (such as compression abdominal bands, elastic stockings, and deep brain stimulation) for non-motor symptoms such as nOH have numerous limitations, including short-term efficacy, uncertain efficacy, and side effects. Therefore, exploring new non-pharmacological treatments to improve nOH and delay disease progression in patients with PDS is crucial for improving their quality of life and prognosis.

Spinal cord stimulation (SCS), including invasive (epidural) spinal cord stimulation (eSCS) and non-invasive (transcutaneous) spinal cord stimulation (tSCS), is a novel neuromodulatory technique with clinical applications in a variety of neurological diseases. Currently, several small-sample studies have suggested the potential efficacy of SCS for nOH caused by spinal cord injury (SCI). This study innovatively proposes the use of eSCS and tSCS to improve nOH and related clinical symptoms in patients with PDS. A prospective, single-center, randomized, controlled clinical trial is planned to compare the efficacy of invasive and non-invasive SCS in treating nOH, thereby providing new insights for the effective treatment of PDS.

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Key information

Conditions

Parkinsonism Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Parkinsonian Disorders

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025 Recruiting

Shanghai, Shanghai Municipality, China

Location contact

Jun LIU, MD, PhD

CONTACT

[email protected]

64370045 ext. +86-021

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Aged between 40 and 80 years;
  • 2. No dementia as measured by the cMMSE scale (formal cMMSE score should be >20 for subjects with 1 to 6 years of formal education; cMMSE score should be >24 for subjects with >6 years of formal education);
  • 3. Able and willing to follow instruction of the researcher;
  • 4. No other conditions that the researchers consider inappropriate for inclusion:

Exclusion criteria

  • 1. Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety;
  • 2. Pregnancy;
  • 3. History of alcoholism;
  • 4. No skin abnormalities;
  • 5. Non-neurological disease-related symptoms that prevent patients from participation in the study.

Treatment and study plan

Epidural Spinal Cord Stimulation

Device

Epidural spinal cord stimulation (eSCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibres to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.

Transcutaneous Spinal Cord Stimulation

Device

Transcutaneous spinal cord stimulation (tSCS) is a non-invasive treatment that improves symptoms by stimulating spinal nerves with pulsed electrical currents via electrodes placed at corresponding spinal cord segments. The tSCS system consists of an electrical pulse stimulator, wires, and conductive patches.

Primary outcomes

  1. Change of blood pressure from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

  2. Change of blood pressure from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 3 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

  3. Change of blood pressure from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 6 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

  4. Change of blood pressure from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

  5. Change of blood pressure from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 12 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

  6. Change of blood pressure from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 18 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

  7. Change of blood pressure from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 24 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Secondary outcomes

  1. Change of oxygen desaturation index from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation

  2. Change of oxygen desaturation index from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation

  3. Change of oxygen desaturation index from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation

  4. Change of oxygen desaturation index from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation

  5. Change of oxygen desaturation index from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation

  6. Change of oxygen desaturation index from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation

  7. Change of oxygen desaturation index from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of oxygen desaturation index measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation

  8. Change of apnea hypopnea index from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation

  9. Change of apnea hypopnea index from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation

  10. Change of apnea hypopnea index from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation

  11. Change of apnea hypopnea index from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation

  12. Change of apnea hypopnea index from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation

  13. Change of apnea hypopnea index from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation

  14. Change of apnea hypopnea index from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of apnea hypopnea index measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation

  15. Change of on-off 24-hour blood pressure monitoring from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to immediately post-operation or post transcutaneous stimulation

  16. Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation or post transcutaneous stimulation

  17. Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation or post transcutaneous stimulation

  18. Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation or post transcutaneous stimulation

  19. Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation or post transcutaneous stimulation

  20. Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation or post transcutaneous stimulation

  21. Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation or post transcutaneous stimulation

  22. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to immediately post-operation or post transcutaneous stimulation

  23. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation or post transcutaneous stimulation

  24. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation or post transcutaneous stimulation

  25. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation or post transcutaneous stimulation

  26. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation or post transcutaneous stimulation

  27. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation or post transcutaneous stimulation

  28. Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation or post transcutaneous stimulation

  29. Change of serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  30. Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  31. Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  32. Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  33. Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  34. Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  35. Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.

  36. Change of on-off delta heart rate variability from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to immediately post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  37. Change of on-off delta heart rate variability from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to 3 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  38. Change of on-off delta heart rate variability from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to 6 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  39. Change of on-off delta heart rate variability from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to 9 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  40. Change of on-off delta heart rate variability from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to 12 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  41. Change of on-off delta heart rate variability from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to 18 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  42. Change of on-off delta heart rate variability from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off delta heart rate variability from baseline to 24 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.

  43. Change of length of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation

  44. Change of length of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation

  45. Change of length of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation

  46. Change of length of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation

  47. Change of length of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation

  48. Change of length of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation

  49. Change of length of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off length of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation

  50. Change of time of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation

  51. Change of time of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation

  52. Change of time of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation

  53. Change of time of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation

  54. Change of time of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation

  55. Change of time of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation

  56. Change of time of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off time of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation

  57. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation

  58. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation

  59. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation

  60. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation

  61. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation

  62. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation

  63. Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation

  64. Change of on-off time to complete the Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation

  65. Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation

  66. Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation

  67. Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation

  68. Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation

  69. Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation

  70. Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation

  71. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to immediately post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  72. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  73. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  74. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  75. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  76. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  77. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.

  78. Change of dysarthria symptom from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to immediately post-operation or post transcutaneous stimulation

  79. Change of dysarthria symptom from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 3 months post-operation or post transcutaneous stimulation

  80. Change of dysarthria symptom from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 6 months post-operation or post transcutaneous stimulation

  81. Change of dysarthria symptom from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 9 months post-operation or post transcutaneous stimulation

  82. Change of dysarthria symptom from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 12 months post-operation or post transcutaneous stimulation

  83. Change of dysarthria symptom from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 18 months post-operation or post transcutaneous stimulation

  84. Change of dysarthria symptom from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 24 months post-operation or post transcutaneous stimulation

  85. Change of urinary retention from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to immediately post-operation or post transcutaneous stimulation

  86. Change of urinary retention from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 3 months post-operation or post transcutaneous stimulation

  87. Change of urinary retention from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 6 months post-operation or post transcutaneous stimulation

  88. Change of urinary retention from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 9 months post-operation or post transcutaneous stimulation

  89. Change of urinary retention from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 12 months post-operation or post transcutaneous stimulation

  90. Change of urinary retention from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 18 months post-operation or post transcutaneous stimulation

  91. Change of urinary retention from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 24 months post-operation or post transcutaneous stimulation

  92. Change of MDS-UPDRS from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to immediately post-operation or post transcutaneous stimulation

  93. Change of MDS-UPDRS from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 3 months post-operation or post transcutaneous stimulation

  94. Change of MDS-UPDRS from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 6 months post-operation or post transcutaneous stimulation

  95. Change of MDS-UPDRS from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 9 months post-operation or post transcutaneous stimulation

  96. Change of MDS-UPDRS from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 12 months post-operation or post transcutaneous stimulation

  97. Change of MDS-UPDRS from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 18 months post-operation or post transcutaneous stimulation

  98. Change of MDS-UPDRS from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 24 months post-operation or post transcutaneous stimulation

  99. Change of UMSARS from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 3 months post-operation or post transcutaneous stimulation

  100. Change of UMSARS from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 6 months post-operation or post transcutaneous stimulation

  101. Change of UMSARS from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 9 months post-operation or post transcutaneous stimulation

  102. Change of UMSARS from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 12 months post-operation or post transcutaneous stimulation

  103. Change of UMSARS from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 18 months post-operation or post transcutaneous stimulation

  104. Change of UMSARS from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 24 months post-operation or post transcutaneous stimulation

  105. Change of UMSARS from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to immediately post-operation or post transcutaneous stimulation

  106. Change of lowest oxygen saturation from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation

  107. Change of lowest oxygen saturation from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation

  108. Change of lowest oxygen saturation from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation

  109. Change of lowest oxygen saturation from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation

  110. Change of lowest oxygen saturation from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation

  111. Change of lowest oxygen saturation from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation

  112. Change of lowest oxygen saturation from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation

  113. Change of mean oxygen saturation from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation

  114. Change of mean oxygen saturation from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation

  115. Change of mean oxygen saturation from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation

  116. Change of mean oxygen saturation from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation

  117. Change of mean oxygen saturation from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation

  118. Change of mean oxygen saturation from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation

  119. Change of mean oxygen saturation from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of mean oxygen saturation measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation

  120. Change of SCOPA-AUT from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to immediately post-operation or post transcutaneous stimulation

  121. Change of SCOPA-AUT from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 3 months post-operation or post transcutaneous stimulation

  122. Change of SCOPA-AUT from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 6 months post-operation or post transcutaneous stimulation

  123. Change of SCOPA-AUT from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 9 months post-operation or post transcutaneous stimulation

  124. Change of SCOPA-AUT from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 12 months post-operation or post transcutaneous stimulation

  125. Change of SCOPA-AUT from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 18 months post-operation or post transcutaneous stimulation

  126. Change of SCOPA-AUT from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 24 months post-operation or post transcutaneous stimulation

  127. Change of delta cerebral artery velocity from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to immediately post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  128. Change of delta cerebral artery velocity from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to 3 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  129. Change of delta cerebral artery velocity from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to 6 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  130. Change of delta cerebral artery velocity from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to 9 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  131. Change of delta cerebral artery velocity from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to 12 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  132. Change of delta cerebral artery velocity from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to 18 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  133. Change of delta cerebral artery velocity from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off delta cerebral artery velocity from baseline to 24 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.

  134. Change of TUG from baseline to immediately post-operation or post transcutaneous stimulation

    Time frame: Immediately post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to immediately post-operation or post transcutaneous stimulation

  135. Change of TUG from baseline to 3 months post-operation or post transcutaneous stimulation

    Time frame: 3 months post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to 3 months post-operation or post transcutaneous stimulation

  136. Change of TUG from baseline to 6 months post-operation or post transcutaneous stimulation

    Time frame: 6 months post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to 6 months post-operation or post transcutaneous stimulation

  137. Change of TUG from baseline to 9 months post-operation or post transcutaneous stimulation

    Time frame: 9 months post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to 9 months post-operation or post transcutaneous stimulation

  138. Change of TUG from baseline to 12 months post-operation or post transcutaneous stimulation

    Time frame: 12 months post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to 12 months post-operation or post transcutaneous stimulation

  139. Change of TUG from baseline to 18 months post-operation or post transcutaneous stimulation

    Time frame: 18 months post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to 18 months post-operation or post transcutaneous stimulation

  140. Change of TUG from baseline to 24 months post-operation or post transcutaneous stimulation

    Time frame: 24 months post surgery or post transcutaneous stimulation

    Change of on-off timed up and go from baseline to 24 months post-operation or post transcutaneous stimulation

Study contacts

Contact information is provided by the study sponsor or research team.

Jun LIU, MD, PhD

CONTACT

[email protected]

021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 7, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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