Status:
RECRUITING
Algorithm Guided DBS Programming in Parkinson's Patients
Lead Sponsor:
Jaslok Hospital and Research Centre
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Parkinson Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06205043
Start Date
January 10 2024
End Date
June 1 2026
Last Update
March 6 2024
Active Locations (1)
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1
Jaslok Hospital And Research Centre
Mumbai, Maharashtra, India, 400026