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PSA Versus STN DBS for DT

NCT ID: NCT06752434

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dystonic Tremor

Keywords

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Dystonic Tremor deep brain stimulation posterior subthalamic area subthalamic nucleus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type DEVICE

active DBS with optimal stimulating parameters

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.

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type DEVICE

active DBS with optimal stimulating parameters

Interventions

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Deep brain stimulation

active DBS with optimal stimulating parameters

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Sceneray Medical Co. , Ltd

INDUSTRY

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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LI DIANYOU

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dianyou Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dianyou Li, MD, PhD

Role: CONTACT

Phone: +0086-021-64370045

Email: [email protected]

Facility Contacts

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Dianyou Li, MD,PhD

Role: primary

Other Identifiers

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DTPSASTN

Identifier Type: -

Identifier Source: org_study_id