Algorithm Guided DBS Programming in Parkinson's Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will be randomized to receive either an algorithm based program vs standard of care program. After a period each group will cross over to the other side. UPDRS assessments will be done at each time.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Clinician based programming

Intervention Type DEVICE

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

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)

Group Type EXPERIMENTAL

StimSearch programming algorithm software

Intervention Type DEVICE

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

Interventions

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StimSearch programming algorithm software

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

Intervention Type DEVICE

Clinician based programming

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No