Localizing Deep Brain Stimulation Leads in Parkinson's Patients
Research on Lead Localization for Deep Brain Stimulation After Implantation
This study is testing if using MRI images can help doctors find the best spots for deep brain stimulation leads in Parkinson's patients to improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tsinghua University Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06196242 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the effectiveness of deep brain stimulation (DBS) for Parkinson's disease by accurately localizing the position of the DBS leads using postoperative MRI images. It will compare the lead positions identified through MRI with those identified through CT scans to evaluate the accuracy of MRI in this context. By optimizing stimulation parameters and identifying the best stimulation targets, the study seeks to enhance treatment outcomes for patients with DBS devices. The research focuses on patients who have had DBS implanted for at least one month.
Who should consider this trial
Good fit: Ideal candidates are Parkinson's disease patients who have had DBS devices implanted for at least one month and can tolerate a temporary turn-off of the device.
Not a fit: Patients with other implanted devices such as pacemakers or those with severe psychiatric disorders or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for Parkinson's disease patients receiving deep brain stimulation.
How similar studies have performed: While deep brain stimulation is a well-established treatment, this specific approach to lead localization using MRI is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parkinson's disease patients with DBS devices, DBS implanted for at least 1 month. * Ability to tolerate DBS turn-off for at least 30 minutes. * DBS devices do not contain the ferromagnetic material. * The patients can fully understand the content of the trial and sign the informed consent form. * Able to comply to the requirements of this study. Exclusion Criteria: * Presence of other concomitant diseases that have or require implantation of pacemakers, defibrillators, cochlear implants, or other neurostimulation devices. * Patients who are abnormally sensitive to temperature or allergic to heat. * Patients with severe psychiatric disorders or cognitive impairment.
Where this trial is running
Beijing, Beijing
- National Engineering Research Center of Neuromodulation — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Feng Zhang, Ph.D.
- Email: zhang-f@mail.tsinghua.edu.cn
- Phone: 86-010-62794952
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.