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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Deep brain stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Dianyou Li, MD,PhD; Email: ldy11483@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PSA-STN; 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.	Device: Deep brain stimulation; active DBS with optimal stimulating parameters
EXPERIMENTAL: STN-PSA; 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.	Device: Deep brain stimulation; active DBS with optimal stimulating parameters

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		up to 12 months after surgery
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months		4 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months		6 months
Change from baseline Timed up and go test to 4 months	in the off-medication condition	4 months
Change from baseline Timed up and go test to 6 months	in the off-medication condition	6 months
Change from baseline Berg balance scale to 4 months	in the off-medication condition	4 months
Change from baseline Berg balance scale to 6 months	in the off-medication condition	6 months
Change from baseline 39-item Parkinsons disease questionnaire to 4 months		4 months
Change from baseline 39-item Parkinsons disease questionnaire to 6 months		6 months
Change from baseline Levodopa equivalent daily dose to 4 months		4 months
Change from baseline Levodopa equivalent daily dose to 6 months		6 months
Change from baseline maximal phonatory time to 4 months		4 months
Change from baseline maximal phonatory time to 6 months		6 months
Change from baseline dysphonia severity index to 4 months		4 months
Change from baseline dysphonia severity index to 6 months		6 months
Change from baseline Mini-Mental Status Exam to 4 months		4 months
Change from baseline Mini-Mental Status Exam to 6 months		6 months
Change from baseline Beck depression inventory to 4 months		4 months
Change from baseline Beck depression inventory to 6 months		6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Suzhou Sceneray Medical Co. , Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2025
• Study Completion (ANTICIPATED): May 1, 2027

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (ACTUAL): May 19, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: deep brain stimulation; subthalamic nucleus; tremor-dominant Parkinson's disease; posterior subthalamic area
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: TDPSA

Drug and device information, study documents

• 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