Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05171205

Spinal Cord Stimulation for Parkinsonism

Spinal Cord Stimulation (SCS) is a newly emerged neuromodulation technique in recent years. It is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. Combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for PDS with SCS. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in Parkinsonism (PDS) patients before and after SCS treatment, and shed new light on the treatment for PDS.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

50 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 Municipality, 200025, China

Location status: Recruiting

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

  • Diagnosed with parkinsonism according to MDS clinical diagnostic criteria for Parkinson's disease
  • Aged between 50 and 80 years
  • Able and willing to follow instruction of the researcher
  • No other conditions that the researchers consider inappropriate for inclusion

Exclusion criteria

  • Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety
  • Pregnancy
  • History of alcoholism
  • Non-neurological disease-related symptoms that prevent patients from participation in the study

Treatment and study plan

Spinal Cord Stimulation

Device

Spinal cord stimulation (SCS) 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 fibers 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.

Primary outcomes

  1. Change of blood pressure from baseline to 3 months post-operation

    Time frame: 3 months

    Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 3 months post-operation. 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 6 months post-operation

    Time frame: 6 months

    Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 6 months post-operation. 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 9 months post-operation

    Time frame: 9 months

    Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 9 months post-operation. 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 12 months post-operation

    Time frame: 12 months

    Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 12 months post-operation. 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 18 months post-operation

    Time frame: 18 months

    Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 18 months post-operation. 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 24 months post-operation

    Time frame: 24 months

    Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 24 months post-operation. 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 3 months post-operation

    Time frame: 3 months

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

  2. Change of oxygen desaturation index from baseline to 6 months post-operation

    Time frame: 6 months

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

  3. Change of oxygen desaturation index from baseline to 9 months post-operation

    Time frame: 9 months

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

  4. Change of oxygen desaturation index from baseline to 12 months post-operation

    Time frame: 12 months

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

  5. Change of oxygen desaturation index from baseline to 18 months post-operation

    Time frame: 18 months

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

  6. Change of oxygen desaturation index from baseline to 24 months post-operation

    Time frame: 24 months

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

  7. Change of apnea hypopnea index from baseline to 3 months post-operation

    Time frame: 3 months

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

  8. Change of apnea hypopnea index from baseline to 6 months post-operation

    Time frame: 6 months

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

  9. Change of apnea hypopnea index from baseline to 9 months post-operation

    Time frame: 9 months

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

  10. Change of apnea hypopnea index from baseline to 12 months post-operation

    Time frame: 12 months

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

  11. Change of apnea hypopnea index from baseline to 18 months post-operation

    Time frame: 18 months

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

  12. Change of apnea hypopnea index from baseline to 24 months post-operation

    Time frame: 24 months

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

  13. Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation

    Time frame: 3 months

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

  14. Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation

    Time frame: 6 months

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

  15. Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation

    Time frame: 9 months

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

  16. Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation

    Time frame: 12 months

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

  17. Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 9 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

  25. Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation

    Time frame: 3 months

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 3 months post-operation. 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.

  26. Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation

    Time frame: 6 months

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 6 months post-operation. 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.

  27. Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation

    Time frame: 9 months

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 9 months post-operation. 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.

  28. Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation

    Time frame: 12 months

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 12 months post-operation. 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.

  29. Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation

    Time frame: 18 months

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 18 months post-operation. 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 24 months post-operation

    Time frame: 24 months

    Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 24 months post-operation. 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 on-off delta heart rate variability from baseline to 3 months post-operation

    Time frame: 3 months

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

  32. Change of on-off delta heart rate variability from baseline to 6 months post-operation

    Time frame: 6 months

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

  33. Change of on-off delta heart rate variability from baseline to 9 months post-operation

    Time frame: 9 months

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

  34. Change of on-off delta heart rate variability from baseline to 12 months post-operation

    Time frame: 12 months

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

  35. Change of on-off delta heart rate variability from baseline to 18 months post-operation

    Time frame: 18 months

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

  36. Change of on-off delta heart rate variability from baseline to 24 months post-operation

    Time frame: 24 months

    Change of on-off delta heart rate variability from baseline to 24 months post-operation. 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 length of walking during 6-minute walking test from baseline to 3 months post-operation

    Time frame: 3 months

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

  38. Change of length of walking during 6-minute walking test from baseline to 6 months post-operation

    Time frame: 6 months

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

  39. Change of length of walking during 6-minute walking test from baseline to 9 months post-operation

    Time frame: 9 months

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

  40. Change of length of walking during 6-minute walking test from baseline to 12 months post-operation

    Time frame: 12 months

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

  41. Change of length of walking during 6-minute walking test from baseline to 18 months post-operation

    Time frame: 18 months

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

  42. Change of length of walking during 6-minute walking test from baseline to 24 months post-operation

    Time frame: 24 months

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

  43. Change of time of walking during 6-minute walking test from baseline to 3 months post-operation

    Time frame: 3 months

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

  44. Change of time of walking during 6-minute walking test from baseline to 6 months post-operation

    Time frame: 6 months

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

  45. Change of time of walking during 6-minute walking test from baseline to 9 months post-operation

    Time frame: 9 months

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

  46. Change of time of walking during 6-minute walking test from baseline to 12 months post-operation

    Time frame: 12 months

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

  47. Change of time of walking during 6-minute walking test from baseline to 18 months post-operation

    Time frame: 18 months

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

  48. Change of time of walking during 6-minute walking test from baseline to 24 months post-operation

    Time frame: 24 months

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 9 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 9 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

  61. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation

    Time frame: 3 months

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

  62. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation

    Time frame: 6 months

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

  63. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation

    Time frame: 9 months

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

  64. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation

    Time frame: 12 months

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

  65. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation

    Time frame: 18 months

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

  66. Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation

    Time frame: 24 months

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

  67. Change of dysarthria symptom from baseline to 3 months post-operation

    Time frame: 3 months

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

  68. Change of dysarthria symptom from baseline to 6 months post-operation

    Time frame: 6 months

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

  69. Change of dysarthria symptom from baseline to 9 months post-operation

    Time frame: 9 months

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

  70. Change of dysarthria symptom from baseline to 12 months post-operation

    Time frame: 12 months

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

  71. Change of dysarthria symptom from baseline to 18 months post-operation

    Time frame: 18 months

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

  72. Change of dysarthria symptom from baseline to 24 months post-operation

    Time frame: 24 months

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

  73. Change of urinary retention from baseline to 3 months post-operation

    Time frame: 3 months

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

  74. Change of urinary retention from baseline to 6 months post-operation

    Time frame: 6 months

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

  75. Change of urinary retention from baseline to 9 months post-operation

    Time frame: 9 months

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

  76. Change of urinary retention from baseline to 12 months post-operation

    Time frame: 12 months

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

  77. Change of urinary retention from baseline to 18 months post-operation

    Time frame: 18 months

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

  78. Change of urinary retention from baseline to 24 months post-operation

    Time frame: 24 months

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

  79. Change of MDS-UPDRS from baseline to 3 months post-operation

    Time frame: 3 months

    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

  80. Change of MDS-UPDRS from baseline to 6 months post-operation

    Time frame: 6 months

    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

  81. Change of MDS-UPDRS from baseline to 9 months post-operation

    Time frame: 9 months

    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

  82. Change of MDS-UPDRS from baseline to 12 months post-operation

    Time frame: 12 months

    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

  83. Change of MDS-UPDRS from baseline to 18 months post-operation

    Time frame: 18 months

    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

  84. Change of MDS-UPDRS from baseline to 24 months post-operation

    Time frame: 24 months

    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

  85. Change of UMSARS from baseline to 3 months post-operation

    Time frame: 3 months

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

  86. Change of UMSARS from baseline to 6 months post-operation

    Time frame: 6 months

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

  87. Change of UMSARS from baseline to 9 months post-operation

    Time frame: 9 months

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

  88. Change of UMSARS from baseline to 12 months post-operation

    Time frame: 12 months

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

  89. Change of UMSARS from baseline to 18 months post-operation

    Time frame: 18 months

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

  90. Change of UMSARS from baseline to 24 months post-operation

    Time frame: 24 months

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

  91. Change of lowest oxygen saturation from baseline to 3 months post-operation

    Time frame: 3 months

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

  92. Change of lowest oxygen saturation from baseline to 6 months post-operation

    Time frame: 6 months

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

  93. Change of lowest oxygen saturation from baseline to 9 months post-operation

    Time frame: 9 months

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

  94. Change of lowest oxygen saturation from baseline to 12 months post-operation

    Time frame: 12 months

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

  95. Change of lowest oxygen saturation from baseline to 18 months post-operation

    Time frame: 18 months

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

  96. Change of lowest oxygen saturation from baseline to 24 months post-operation

    Time frame: 24 months

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

  97. Change of mean oxygen saturation from baseline to 3 months post-operation

    Time frame: 3 months

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

  98. Change of mean oxygen saturation from baseline to 6 months post-operation

    Time frame: 6 months

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

  99. Change of mean oxygen saturation from baseline to 9 months post-operation

    Time frame: 9 months

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

  100. Change of mean oxygen saturation from baseline to 12 months post-operation

    Time frame: 12 months

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

  101. Change of mean oxygen saturation from baseline to 18 months post-operation

    Time frame: 18 months

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

  102. Change of mean oxygen saturation from baseline to 24 months post-operation

    Time frame: 24 months

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

  103. Change of SCOPA-AUT from baseline to 3 months post-operation

    Time frame: 3 months

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

  104. Change of SCOPA-AUT from baseline to 6 months post-operation

    Time frame: 6 months

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

  105. Change of SCOPA-AUT from baseline to 9 months post-operation

    Time frame: 9 months

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

  106. Change of SCOPA-AUT from baseline to 12 months post-operation

    Time frame: 12 months

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

  107. Change of SCOPA-AUT from baseline to 18 months post-operation

    Time frame: 18 months

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

  108. Change of SCOPA-AUT from baseline to 24 months post-operation

    Time frame: 24 months

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

  109. Change of delta cerebral artery velocity from baseline to 3 months post-operation

    Time frame: 3 months

    Change of on-off delta cerebral artery velocity from baseline to 3 months post-operation. 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.

  110. Change of delta cerebral artery velocity from baseline to 6 months post-operation

    Time frame: 6 months

    Change of on-off delta cerebral artery velocity from baseline to 6 months post-operation. 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.

  111. Change of delta cerebral artery velocity from baseline to 9 months post-operation

    Time frame: 9 months

    Change of on-off delta cerebral artery velocity from baseline to 9 months post-operation. 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.

  112. Change of delta cerebral artery velocity from baseline to 12 months post-operation

    Time frame: 12 months

    Change of on-off delta cerebral artery velocity from baseline to 12 months post-operation. 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.

  113. Change of delta cerebral artery velocity from baseline to 18 months post-operation

    Time frame: 18 months

    Change of on-off delta cerebral artery velocity from baseline to 18 months post-operation. 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.

  114. Change of delta cerebral artery velocity from baseline to 24 months post-operation

    Time frame: 24 months

    Change of on-off delta cerebral artery velocity from baseline to 24 months post-operation. 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.

  115. Change of TUG from baseline to 3 months post-operation

    Time frame: 3 months

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

  116. Change of TUG from baseline to 6 months post-operation

    Time frame: 6 months

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

  117. Change of TUG from baseline to 9 months post-operation

    Time frame: 9 months

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

  118. Change of TUG from baseline to 12 months post-operation

    Time frame: 12 months

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

  119. Change of TUG from baseline to 18 months post-operation

    Time frame: 18 months

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

  120. Change of TUG from baseline to 24 months post-operation

    Time frame: 24 months

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

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

Official study title

Spinal Cord Stimulation for Parkinsonism: a Single-center, Single-arm Open Trial

Acronym: SCS for PDS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 28, 2021
Registry last updated
May 9, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.