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

Movement Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488837
• Other study ID #: F140225003
• Status: Completed
• Start date: June 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Movement Disorders

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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