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

NCT ID: NCT02488837

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Movement Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DBS subjects

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Harrison Walker, MD

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harrison Walker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F140225003

Identifier Type: -

Identifier Source: org_study_id

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