RECRUITINGINTERVENTIONAL
Algorithm Guided DBS Programming in 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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form before undergoing any study-specific tests or procedures
Who Should NOT Join This Trial:
- Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
StimSearch programming algorithm software
This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease
DEVICE
Clinician based programming
This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease
Locations (1)
Jaslok Hospital And Research Centre
Mumbai, Maharashtra, India