Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06752434

PSA Versus STN DBS for DT

Led by Ruijin Hospital · Updated on 2024-12-30

20

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

R

Ruijin Hospital

Lead Sponsor

S

Suzhou Sceneray Medical Co. , Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PSA Versus STN DBS for DT

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with dystonic tremor based on the MDS 2018 consensus
  • Motor symptoms of dystonic tremor present for 3 or more years
  • Stable tremor medication doses for at least 28 days prior to consent if applicable
  • Good compliance with study procedures and written informed consent provided
Not Eligible

You will not qualify if you...

  • Intracranial abnormalities preventing DBS surgery
  • Significant mental illness affecting study compliance (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
  • Severe cognitive impairment with MOCA score below 24
  • Current substance or alcohol abuse as defined by DSM-V
  • History of recurrent or unprovoked epileptic seizures
  • Prior intracranial surgery or device implantation for movement disorders
  • History of hemorrhagic stroke
  • Significant medical conditions interfering with study or confounding assessments
  • Terminal illness with life expectancy less than 1 year

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

D

Dianyou Li, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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