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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02488837

Enrollment

Registered

2015-07-02

Start date

2014-06-30

Completion date

2016-12-01

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Movement Disorders

Keywords

Deep Brain Stimulation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Deep Brain Stimulation (DBS) Therapeutic Window	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
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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
The Essential Tremor Rating Assessment Scale (TETRAS)	Change in the rating scale score at 6 months post-op versus pre-op baseline	Validated rating scale for measuring symptoms of essential tremor
Burke-Fahn-Marsden (BFM) Dystonia Rating Scale	Change in the rating scale score at 6 months post-op versus pre-op baseline	Validated rating scale for measuring symptoms of primary dystonia
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)	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
Yale Global Tic Severity Scale	Change in the rating scale score at 6 months post-op versus pre-op baseline	Validated rating scale for tic severity

Countries

United States

Outcome results