Algorithm Guided DBS Programming in Parkinson's Patients

N/AUnknownNCT06205043

Jaslok Hospital and Research Centre30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

StimSearch programming algorithm softwareDEVICE

This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease

Clinician based programmingDEVICE

This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Jaslok Hospital And Research Centre

Mumbai, Maharashtra, India

RECRUITING

Outcomes

Primary Outcomes

Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.

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.

Time frame: 4 weeks

Comparison of time required between StimSearch and SOC programming

Total time in minutes will recorded

Time frame: 4 weeks

Secondary Outcomes

Comparison of volume of tissue activated (VTA) between StimSearch and SOC

The volume of tissue activated in cubic millimeter will be calculated.

Time frame: 4 weeks

Comparison of target volume between StimSearch and SOC

The target volume in cubic millimeter will be calculated.

Time frame: 4 weeks

Central Contacts

Paresh Doshi, MCh

CONTACT

+91 9820063854 pareshkd@gmail.com

Data from ClinicalTrials.gov

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