Clinical trial NCT02488837: Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing DBS for Movement Disorders
Official title: Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing Deep Brain Stimulation for Movement Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Keywords: Deep Brain Stimulation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2015-07-02
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Change in the rating scale score at 6 months post-op versus pre-op baseline
measure: The Essential Tremor Rating Assessment Scale (TETRAS)
timeFrame: Change in the rating scale score at 6 months post-op versus pre-op baseline
measure: Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
timeFrame: Change in the rating scale score at 6 months post-op versus pre-op baseline
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Change in the rating scale score at 6 months post-op versus pre-op baseline
measure: Yale Global Tic Severity Scale
timeFrame: Change in the rating scale score at 6 months post-op versus pre-op baseline
measure: Deep Brain Stimulation (DBS) Therapeutic Window
timeFrame: 1 month post-operative scores for each contact on the DBS electrode array
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Harrison Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: