Comparing two deep brain stimulation techniques for treating dystonic tremor
Official title: Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: a Prospective, Randomized, Double-blinded, Cross-over Trial
Run by Ruijin Hospital · NCT06752434 · Data updated 2026-11-12
This study is testing which deep brain stimulation technique works better for treating dystonic tremor by comparing two different brain areas in patients who have the condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | December 2024 |
| Main results expected | March 2027 |
| Study ends | March 2029 |
| Registry record updated | December 30, 2024 |
| Trial ID | NCT06752434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with dystonic tremor for at least three years who meet specific inclusion criteria.
✕Probably not a fit
Patients with significant mental illness, severe cognitive impairment, or other medical conditions that interfere with the study may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of deep brain stimulation (DBS) in the posterior subthalamic area (PSA) compared to the subthalamic nucleus (STN) for patients with dystonic tremor. It is designed as a randomized, double-blinded, crossover trial where participants will undergo bilateral DBS surgery targeting both areas. After a three-month recovery period, patients will switch between PSA and STN stimulation in a randomized order over four months. The study will conclude with an open-label phase allowing unrestricted programming parameters until the 12-month follow-up.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective DBS technique for alleviating dystonic tremor symptoms.
How similar studies have gone: While there have been studies on DBS for movement disorders, this specific comparison of PSA versus STN DBS for dystonic tremor is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Dianyou Li, MD, PhD — Ruijin Hospital
- Study coordinator: Dianyou Li, MD, PhD
- Email: ldy11483@rjh.com.cn
- Phone: +0086-021-64370045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.