Using an algorithm to guide deep brain stimulation programming for Parkinson's patients
Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
NA · Jaslok Hospital and Research Centre · NCT06205043
This study tests if using a special computer program to adjust deep brain stimulation can help people with Parkinson's disease feel better compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Jaslok Hospital and Research Centre (other) |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06205043 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an algorithm-based programming approach for deep brain stimulation (DBS) in patients with Parkinson's disease compared to standard care programming. Patients who have already undergone bilateral subthalamic nucleus stimulation will be randomly assigned to receive either algorithm-guided programming or standard programming. After a stabilization period, their motor improvements will be assessed, and they will switch to the alternative programming method for further evaluation. The study aims to analyze various parameters, including the efficiency and effectiveness of the different programming techniques.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of bilateral idiopathic Parkinson's disease who meet specific motor function criteria.
Not a fit: Patients with significant psychiatric conditions, including clinically substantial depression, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and efficient programming of DBS, improving motor function in Parkinson's patients.
How similar studies have performed: While the use of algorithm-based programming in DBS is a novel approach, similar studies have shown promise in improving outcomes for patients with neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a confirmed diagnosis of bilateral idiopathic Parkinson's disease * Exhibit a UPDRS subset III score of ≥ 25 while in the preoperative medication off state * Demonstrate an improvement of Parkinson's disease symptoms by ≥30% in the medication off state following a pre-operative levodopa challenge, as assessed by the UPDRS subset III score * Possess the ability to comprehend the study's demands, treatment protocols, and procedures, and provide written informed consent before undergoing any study-specific tests or procedures Exclusion Criteria: * Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
Where this trial is running
Mumbai, Maharashtra
- Jaslok Hospital And Research Centre — Mumbai, Maharashtra, India (RECRUITING)
Study contacts
- Principal investigator: Paresh Doshi, MCh — Jaslok Hospital and Research Center
- Study coordinator: Paresh Doshi, MCh
- Email: pareshkd@gmail.com
- Phone: +91 9820063854
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.
Conditions: Parkinson Disease, Deep brain stimulation, Programming, Parkinson disease