Algorithm Guided DBS Programming in Parkinson's Patients

March 5, 2024 updated by: Paresh doshi, Jaslok Hospital and Research Centre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400026
        • Recruiting
        • Jaslok Hospital and Research Centre
        • Contact:
        • Principal Investigator:
          • Paresh K Doshi, MCh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care (SoC) based programming in Parkinson's disease patients
Patients will be programmed in a routine (Standard of Care) program. Based on the randomization the patient may receive this at the beginning or after the Stim search program (crossover)
Device: Clinician based programming
This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease
Experimental: StimSearchTM software based programing in Parkinson's disease patients
Patients will be programmed using StimSearch algorithm. Based on the randomization the patient may receive this at the beginning or after the Standard of Care program (crossover)
Device: StimSearch programming algorithm software
This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.
Time Frame: 4 weeks
Unified Parkinson's disease rating scale scores (part III) will be used to evaluate this. Range (0-132) The lower the score indicates lesser severity of the disease and improved outcome.
4 weeks
Comparison of time required between StimSearch and SOC programming
Time Frame: 4 weeks
Total time in minutes will recorded
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of volume of tissue activated (VTA) between StimSearch and SOC
Time Frame: 4 weeks
The volume of tissue activated in cubic millimeter will be calculated.
4 weeks
Comparison of target volume between StimSearch and SOC
Time Frame: 4 weeks
The target volume in cubic millimeter will be calculated.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaslok Hospital and Research Centre

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Paresh Doshi, MCh, Jaslok Hospital and Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stimulation Search

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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