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OpenTrials
Completed

NCT Number: NCT02488837

Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing DBS 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.

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Key information

Conditions

Movement Disorders Central Nervous System Diseases Nervous System Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients who are outside the age range for inclusion
  • 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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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