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

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

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.

Study Overview

• Status: Completed
• Conditions: Movement Disorders

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Medtronic
• Investigators: Principal Investigator: Harrison Walker, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders
• Other Study ID Numbers: F140225003