Comparing two methods of deep brain stimulation for Parkinson's disease
Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
This study is testing which method of deep brain stimulation—constant current or constant voltage—works better and makes people with Parkinson's disease happier after their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06742450 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and patient satisfaction of constant current versus constant voltage deep brain stimulation in patients with Parkinson's disease. It is a randomized, parallel controlled, multi-center trial involving approximately 180 participants who will be followed for up to 12 months after surgery. Participants will be assigned to either current mode or voltage mode of stimulation and will undergo comprehensive assessments at baseline and during follow-up. The study will evaluate programming burden, power consumption, and overall satisfaction from both physicians and patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with idiopathic Parkinson's disease who have undergone bilateral subthalamic nucleus deep brain stimulation but have not yet powered on the device.
Not a fit: Patients with mental disorders, serious health conditions, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved deep brain stimulation techniques that enhance patient outcomes and satisfaction.
How similar studies have performed: Other studies have explored deep brain stimulation techniques, but this specific comparison of current versus voltage modes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with idiopathic Parkinson's disease * Aged 18 to 75, no limited sex * After bilateral STN-DBS, yet not powered on Exclusion Criteria: * Mental disorders or dementia * Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy * Serious health conditions, such as tumors, liver or kidney diseases, etc. * Epilepsy or other seizure disorders * Patients with severely deviated electrode placement * Patients who were unable to voluntarily sign an informed consent form * Patients who did not agree to cooperate with follow-up
Where this trial is running
Beijing
- Xuanwu Hospital of Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shanshan Mei
- Email: sophy33@163.com
- Phone: +86 13426263236
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.