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

Completed

• Conditions: Movement Disorders

• Registration Number: NCT02488837
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. 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).
2. Adults, ages 19 and older

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Exclusion Criteria

1. Patients who are outside the age range for inclusion
2. Patients who are unable to consent to the research for cognitive or behavioral reasons
3. Patients who are medically too ill to participate, and
4. Patients who have their DBS programming at outside facilities

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States