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

NCT02488837 | Completed

• 1 other identifier: F140225003
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement Disorders

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

DBS subjects

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).
• Adults, ages 19 and older

You may not qualify if:

• Patients who are unable to consent to the research for cognitive or behavioral reasons
• Patients who are medically too ill to participate, and
• Patients who have their DBS programming at outside facilities

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Medtronic: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Harrison Walker, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)