Comparing deep brain stimulation techniques for tremor-dominant Parkinson's disease
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
This study is testing which deep brain stimulation technique works better for people with tremor-dominant Parkinson's disease by comparing two different brain areas to see which helps reduce tremors more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05382858 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of deep brain stimulation (DBS) in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for treating tremor-dominant Parkinson's disease. It is designed as a randomized, double-blinded, crossover trial where patients will undergo bilateral DBS surgery targeting both areas. After a two-month recovery period, participants will switch between PSA and STN stimulation in a randomized order over four months. The study will continue with an open-label phase for an additional six months to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with idiopathic Parkinson's disease exhibiting a tremor-dominant subtype and meeting specific clinical criteria.
Not a fit: Patients with atypical parkinsonism or significant cognitive and psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective DBS technique for managing tremor-dominant Parkinson's disease, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored DBS for Parkinson's disease, but this specific comparison of PSA versus STN is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.