Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488837
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Harrison Walker, MD, 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.

Condition or disease
Movement Disorders

Layout table for study information
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 : June 2014
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who undergo deep brain stimulation as part of routine clinical care for movement disorders (Parkinson's disease, essential tremor, dystonia, Tourette's syndrome).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488837


Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Harrison Walker, MD University of Alabama at Birmingham

Layout table for additonal information
Responsible Party: Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02488837     History of Changes
Other Study ID Numbers: F140225003
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Keywords provided by Harrison Walker, MD, University of Alabama at Birmingham:
Deep Brain Stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Movement Disorders
Disease
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases