PSA Versus STN DBS for DT (PSA-STN)

Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: 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 dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.

Study Overview

• Status: Recruiting
• Conditions: Dystonic Tremor
• 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 dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 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 (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dianyou Li, MD, PhD; Phone Number: +0086-021-64370045; Email: ldy11483@rjh.com.cn

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; Phone Number: +0086-021-64370045; Email: ldy11483@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with dystonic tremor based on the MDS 2018 consensus
• Duration of DT symptoms: ≥3 years of motor symptoms
• If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
• Good compliance and written informed consent

Exclusion Criteria:

• Any intracranial abnormalities that would prevent DBS surgery
• Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
• Severe cognitive impairment, MOCA score <24
• Any current substance or alcohol abuse according to DSM-V criteria
• Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
• Any terminal illness with a life expectancy of <1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• 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	Time Frame
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months	5 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months	7 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	up to 12 months after surgery
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months	5 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months	7 months
Change from baseline Mini-Mental Status Exam to 5 months	5 months
Change from baseline Mini-Mental Status Exam to 7 months	7 months
Change from baseline Beck depression inventory to 5 months	5 months
Change from baseline Beck depression inventory to 7 months	7 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Beijing Pins Medical Co., Ltd; Suzhou Sceneray Medical Co. , Ltd
• Investigators: Principal Investigator: Dianyou Li, MD, PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: deep brain stimulation; subthalamic nucleus; Dystonic Tremor; posterior subthalamic area
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Dyskinesias; Tremor
• Other Study ID Numbers: DTPSASTN

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