Algorithm Guided DBS Programming in Parkinson's Patients

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: StimSearch programming algorithm software; Device: Clinician based programming

• Registration Number: NCT06205043
• Lead Sponsor: Jaslok Hospital and Research Centre

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 including the effectivity and efficiency of algorithm programming will be compared against the standard of care programming.

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 Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2024-01-03
• Study Start: 2024-01-10
• Study First Posted: 2024-01-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2026-02-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
StimSearchTM software based programing in Parkinson's disease patients	StimSearch programming algorithm software	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)
Standard of care (SoC) based programming in Parkinson's disease patients	Clinician based programming	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)

Primary Outcome Measures

Name	Time	Method
Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.	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.
Comparison of time required between StimSearch and SOC programming	4 weeks	Total time in minutes will recorded

Secondary Outcome Measures

Name	Time	Method
Comparison of volume of tissue activated (VTA) between StimSearch and SOC	4 weeks	The volume of tissue activated in cubic millimeter will be calculated.
Comparison of target volume between StimSearch and SOC	4 weeks	The target volume in cubic millimeter will be calculated.

Trial Locations

Locations (1)

Jaslok Hospital And Research Centre; 🇮🇳 Mumbai, Maharashtra, India