Algorithm Guided DBS Programming in Parkinson's Patients

Jaslok Hospital and Research Centre

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Clinician based programming; Device: StimSearch programming algorithm software

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06205043

Stimulation Search

Details and patient eligibility

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Standard of care (SoC) based programming in Parkinson's disease patients

Active Comparator group

Description:

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)

Treatment:

Device: Clinician based programming

StimSearchTM software based programing in Parkinson's disease patients

Experimental group

Description:

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)

Treatment:

Device: StimSearch programming algorithm software