Closed-loop deep brain stimulation for Parkinson's disease
Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study
This study is testing if a new type of brain stimulation that adjusts to a person's needs can help people with Parkinson's disease manage their symptoms better than the usual method.
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 | NCT06012461 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term safety and effectiveness of closed-loop deep brain stimulation (DBS) in patients with Parkinson's disease. It aims to dynamically adjust stimulation parameters based on the patient's disease fluctuations and activity state. Participants will receive both closed-loop and open-loop DBS stimulation for varying durations to compare their effectiveness in managing Parkinson's symptoms. The study seeks to determine if closed-loop DBS offers superior outcomes compared to traditional open-loop DBS.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary Parkinson's disease who experience significant motor complications and have a good response to levodopa therapy.
Not a fit: Patients with secondary Parkinson syndromes, those who have had previous brain surgeries, or those with severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of Parkinson's disease symptoms and enhanced quality of life for patients.
How similar studies have performed: Other studies have shown promise with closed-loop DBS approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015. 2. Good response to levodopa combination therapy. 3. Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications. 4. Intolerable adverse reactions to medication affecting its efficacy. 5. Presence of uncontrollable tremors despite medication. Exclusion Criteria: 1. Patients who have undergone pallidotomy or other brain surgeries. 2. Patients with secondary Parkinson syndromes or Parkinson plus syndromes. 3. Patients with concurrent central nervous system and peripheral nervous system diseases. 4. Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments. 5. Patients with severe psychiatric disorders. 6. Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
Where this trial is running
Beijing, Beijing
- National Engineering Research Center of Neuromodulation — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Weizhi Pan, B.S.
- Email: neln@mail.tsinghua.edu.cn
- Phone: +86-010-62796172
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.