Actively Recruiting

Phase Not Applicable
All Genders
NCT06205043

Algorithm Guided DBS Programming in Parkinson's Patients

Led by Jaslok Hospital and Research Centre · Updated on 2024-03-06

30

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

J

Jaslok Hospital and Research Centre

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Algorithm Guided DBS Programming in Parkinson's Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a confirmed diagnosis of bilateral idiopathic Parkinson's disease
  • Exhibit a UPDRS subset III score of �3e 25 while in the preoperative medication off state
  • Demonstrate an improvement of Parkinson's disease symptoms by �3e30% 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
Not Eligible

You will not qualify if you...

  • Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jaslok Hospital And Research Centre

Mumbai, Maharashtra, India, 400026

Actively Recruiting

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Research Team

P

Paresh Doshi, MCh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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