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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT02488837
Collaborator
Medtronic (Industry)
21
Enrollment
1
Location
30
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing Deep Brain Stimulation for Movement Disorders
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    DBS subjects

    deep brain stimulation (DBS) in patients with Parkinson's disease, tremor, dystonia, and Tourette's syndrome

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • Medtronic

    Investigators

    • Principal Investigator: Harrison Walker, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT02488837
    Other Study ID Numbers:
    • F140225003
    First Posted:
    Jul 2, 2015
    Last Update Posted:
    May 11, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham
    Deep Brain Stimulation
    Additional relevant MeSH terms:
    Movement Disorders

    Study Results

    No Results Posted as of May 11, 2018