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Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
Patients undergoing Deep Brain Stimulation for Parkinson's disease will be subjected to standard of care programming and compared with the algorithm based programming (StimSearch). Various parameters including the effectivity and efficiency of algorithm programming will be compared against the standard of care programming.
Patients of Parkinson's disease undergoing bilateral subthalamic nucleus stimulation (STN), we have already been adequately programmed and have achieved good outcome, will undergo an exploratory study to evaluate the effectiveness of algorithm based programming (Phase 1). Subsequently, patients undergoing STN DBS will be randomly allocated to algorithm based programming/ standard of care programming and after adequate stabilisation evaluated for motor improvement. They will be switched over to the alternative technique of programming and evaluated again after a similar period. Data regarding the time consumed, effectivity and several secondary endpoints will be evaluated.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Jaslok Hospital And Research Centre
Mumbai, Maharashtra, India
Start Date
January 10, 2024
Primary Completion Date
February 1, 2026
Completion Date
June 1, 2026
Last Updated
March 6, 2024
30
ESTIMATED participants
StimSearch programming algorithm software
DEVICE
Clinician based programming
DEVICE
Lead Sponsor
Jaslok Hospital and Research Centre
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06113640