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PSA Versus STN DBS for TD-PD (PSA-STN)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring tremor-dominant Parkinson's disease, deep brain stimulation, posterior subthalamic area, subthalamic nucleus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of idiopathic Parkinson's disease
  • tremor-dominant subtype in the on-medication condition
  • dopamine-resistant tremor (i.e., preoperative levodopa responsiveness < 24% regarding the tremor subscore of the MDS UPDRS-III or uncontrolled tremor regardless of LEDD over 900 mg or maximal tolerated dose)

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

Sites / Locations

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PSA-STN

STN-PSA

Arm Description

Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months.

Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months.

Outcomes

Primary Outcome Measures

Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 4 months
in the off-medication condition
Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
in the off-medication condition

Secondary Outcome Measures

Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months
Change from baseline Timed up and go test to 4 months
in the off-medication condition
Change from baseline Timed up and go test to 6 months
in the off-medication condition
Change from baseline Berg balance scale to 4 months
in the off-medication condition
Change from baseline Berg balance scale to 6 months
in the off-medication condition
Change from baseline 39-item Parkinsons disease questionnaire to 4 months
Change from baseline 39-item Parkinsons disease questionnaire to 6 months
Change from baseline Levodopa equivalent daily dose to 4 months
Change from baseline Levodopa equivalent daily dose to 6 months
Change from baseline maximal phonatory time to 4 months
Change from baseline maximal phonatory time to 6 months
Change from baseline dysphonia severity index to 4 months
Change from baseline dysphonia severity index to 6 months
Change from baseline Mini-Mental Status Exam to 4 months
Change from baseline Mini-Mental Status Exam to 6 months
Change from baseline Beck depression inventory to 4 months
Change from baseline Beck depression inventory to 6 months
Adverse events

Full Information

First Posted
May 1, 2022
Last Updated
February 12, 2023
Sponsor
Ruijin Hospital
Collaborators
Suzhou Sceneray Medical Co. , Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05382858
Brief Title
PSA Versus STN DBS for TD-PD
Acronym
PSA-STN
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Suzhou Sceneray Medical Co. , Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
tremor-dominant Parkinson's disease, deep brain stimulation, posterior subthalamic area, subthalamic nucleus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSA-STN
Arm Type
Experimental
Arm Description
Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months.
Arm Title
STN-PSA
Arm Type
Experimental
Arm Description
Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months.
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
active DBS with optimal stimulating parameters
Primary Outcome Measure Information:
Title
Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 4 months
Description
in the off-medication condition
Time Frame
4 months
Title
Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
Description
in the off-medication condition
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months
Time Frame
4 months
Title
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months
Time Frame
6 months
Title
Change from baseline Timed up and go test to 4 months
Description
in the off-medication condition
Time Frame
4 months
Title
Change from baseline Timed up and go test to 6 months
Description
in the off-medication condition
Time Frame
6 months
Title
Change from baseline Berg balance scale to 4 months
Description
in the off-medication condition
Time Frame
4 months
Title
Change from baseline Berg balance scale to 6 months
Description
in the off-medication condition
Time Frame
6 months
Title
Change from baseline 39-item Parkinsons disease questionnaire to 4 months
Time Frame
4 months
Title
Change from baseline 39-item Parkinsons disease questionnaire to 6 months
Time Frame
6 months
Title
Change from baseline Levodopa equivalent daily dose to 4 months
Time Frame
4 months
Title
Change from baseline Levodopa equivalent daily dose to 6 months
Time Frame
6 months
Title
Change from baseline maximal phonatory time to 4 months
Time Frame
4 months
Title
Change from baseline maximal phonatory time to 6 months
Time Frame
6 months
Title
Change from baseline dysphonia severity index to 4 months
Time Frame
4 months
Title
Change from baseline dysphonia severity index to 6 months
Time Frame
6 months
Title
Change from baseline Mini-Mental Status Exam to 4 months
Time Frame
4 months
Title
Change from baseline Mini-Mental Status Exam to 6 months
Time Frame
6 months
Title
Change from baseline Beck depression inventory to 4 months
Time Frame
4 months
Title
Change from baseline Beck depression inventory to 6 months
Time Frame
6 months
Title
Adverse events
Time Frame
up to 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianyou Li, MD, PhD
Phone
+0086-021-64370045
Email
ldy11483@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianyou Li, MD, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianyou Li, MD,PhD
Email
ldy11483@rjh.com.cn

12. IPD Sharing Statement

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PSA Versus STN DBS for TD-PD

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