Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing DBS for Movement Disorders

Study Overview
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Brief Summary
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The purpose of the study is to determine if non-invasive measurements of brain waves from the skin called electroencephalography (EEG) can predict whether the brain stimulator will help your symptoms. Our goal is to obtain these brain wave measurements with patients both awake and under general anesthesia, and then to evaluate which brain wave patterns are associated with clinical improvement to determine if they could be useful for predicting whether the surgery will work. If such predictive measures were established based upon the findings of this study, they could be used in the future to improve surgical outcomes in the following ways: (1) to help guide surgical targeting in the operating room awake or under anesthesia, (2) to guide post-operative programming in clinic, and (3) and to develop potential feedback systems for automatic programming of the brain stimulator system at home.

Official Title
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Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing Deep Brain Stimulation for Movement Disorders

Conditions
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Movement Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who elect to undergo deep brain stimulation as part of routine clinical care for movement disorders (Parkinson's disease, essential tremor, dystonia, Tourette's syndrome). Adults, ages 19 and older Exclusion Criteria: Patients who are outside the age range for inclusion Patients who are unable to consent to the research for cognitive or behavioral reasons Patients who are medically too ill to participate, and Patients who have their DBS programming at outside facilities

Ages Eligible for Study
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Minimum Age: 19 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DBS subjects<br>deep brain stimulation (DBS) in patients with Parkinson's disease, tremor, dystonia, and Tourette's syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Validated rating scale for measuring symptoms of Parkinson's disease | Change in the rating scale score at 6 months post-op versus pre-op baseline | 
| The Essential Tremor Rating Assessment Scale (TETRAS) | Validated rating scale for measuring symptoms of essential tremor | Change in the rating scale score at 6 months post-op versus pre-op baseline | 
| Burke-Fahn-Marsden (BFM) Dystonia Rating Scale | Validated rating scale for measuring symptoms of primary dystonia | Change in the rating scale score at 6 months post-op versus pre-op baseline | 
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Validated rating scale for measuring symptoms of primary cervical/segmental dystonia | Change in the rating scale score at 6 months post-op versus pre-op baseline | 
| Yale Global Tic Severity Scale | Validated rating scale for tic severity | Change in the rating scale score at 6 months post-op versus pre-op baseline | 
| Deep Brain Stimulation (DBS) Therapeutic Window | Measurement of the available range of stimulation intensities for therapy for each contact on the DBS electrode array | 1 month post-operative scores for each contact on the DBS electrode array | 

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