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Completed

NCT Number: NCT05382858

PSA Versus STN DBS for TD-PD

The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of idiopathic Parkinson's disease
  • tremor-dominant subtype in the on-medication condition
  • modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition
  • receiving regular anti-parkinsonian drugs for more than 6 weeks
  • good compliance and written informed consent provided

Exclusion criteria

  • Atypical parkinsonism
  • History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
  • Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
  • Presence of anatomical abnormalities in the target region
  • Clinically significant medical history that would increase pre-/post-operative complications
  • Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

Treatment and study plan

Deep brain stimulation

Device

active DBS with optimal stimulating parameters

Primary outcomes

  1. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase

    Time frame: up to 6 months

    in the off-medication condition

Secondary outcomes

  1. Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  2. Change from baseline MDS UPDRS-III to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  3. Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  4. Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  5. Change from baseline Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  6. Change from baseline Timed up and go test (TUG) to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  7. Change from baseline Berg balance scale to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  8. Change from baseline Berg balance scale to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

    in the off-medication condition

  9. Change from baseline 39-item Parkinsons disease questionnaire to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  10. Change from baseline 39-item Parkinsons disease questionnaire to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  11. Change from baseline Levodopa equivalent daily dose to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  12. Change from baseline Levodopa equivalent daily dose to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  13. Change from baseline maximal phonatory time to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  14. Change from baseline maximal phonatory time to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  15. Change from baseline dysphonia severity index to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  16. Change from baseline dysphonia severity index to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  17. Change from baseline Mini-Mental Status Exam to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  18. Change from baseline Mini-Mental Status Exam to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  19. Change from baseline Beck depression inventory to the end of PSA stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  20. Change from baseline Beck depression inventory to the end of STN stimulation phase in the randomization phase

    Time frame: up to 6 months (4-6 months depending on randomization arm)

  21. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the MDS UPDRS-III in the randomized phase

    Time frame: up to 6 months

    in the off-medication condition

  22. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Fahn-Tolosa-Marin Clinical Rating Scale in the randomized phase

    Time frame: up to 6 months

    in the off-medication condition

  23. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Timed up and go test (TUG) in the randomized phase

    Time frame: up to 6 months

    in the off-medication condition

  24. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Berg balance scale in the randomized phase

    Time frame: up to 6 months

    in the off-medication condition

  25. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the 39-item Parkinson's disease questionnaire in the randomized phase

    Time frame: up to 6 months

  26. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the levodopa equivalent daily dose in the randomized phase

    Time frame: up to 6 months

  27. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the beck depression inventory in the randomized phase

    Time frame: up to 6 months

  28. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the maximal phonatory time in the randomized phase

    Time frame: up to 6 months

  29. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the dysphonia severity index in the randomized phase

    Time frame: up to 6 months

  30. Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Mini-Mental Status Exam in the randomized phase

    Time frame: up to 6 months

  31. Adverse events

    Time frame: up to 12 months after surgery

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Suzhou Sceneray Medical Co. , Ltd

Registry information

Official study title

Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial

Acronym: PSA-STN

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 19, 2022
Registry last updated
Dec 2, 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.

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