Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.

Official Title
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Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Deep Brain Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS. On stable dose of dopaminergic drugs Age 45-70 years of age Exclusion Criteria: Past medical history of seizures Renal insufficiency Cardiac arrhythmia Severe arthritis Women of childbearing potential Dementia Less than 45 years of age or older than 70 years of age

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral stimulation<br>Participants will receive Deep Brain Stimulation Bilaterally. | Device: Deep Brain Stimulator<br>* DBS will provide brain stimulation.<br>* Other names: DBS;|
| Experimental: Left stimulation<br>Participants will receive Deep Brain Stimulation on the left side only | Device: Deep Brain Stimulator<br>* DBS will provide brain stimulation.<br>* Other names: DBS;|
| Experimental: Right stimulation<br>Participants will receive Deep Brain Stimulation on the right side only | Device: Deep Brain Stimulator<br>* DBS will provide brain stimulation.<br>* Other names: DBS;|
| No Intervention: Off stimulation<br>Participants will receive no brain stimulation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Speed | Walking speed will be measured using sensors reported in meter per second. | Up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stride Length | Stride length will be measured using sensors and will be reported in meters. | Up to 1 hour | 
| UPDRS Scores | Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition. | Up to 1 hour | 
| TUG Test | Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair. | Up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation