Stroke Rehabilitation Using BCI Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Action Research Arm Test Scores
Study Overview
Brief Summary
The purpose of this research is to determine if functional muscle stimulation, directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.
Detailed Description
Ongoing research (NCT02098265) suggests that noninvasive EEG driven Brain Computer Interface (BCI) systems hold the potential for facilitating recovery in the chronic phase after stroke by synchronizing central or brain activity with peripheral movements and thereby harnessing brain plasticity.
The specific aims of this study are:
Aim 1: To investigate the efficacy of active FES vs. passive FES, as measured by changes in behavioral measures. The investigators hypothesize that improvements in motor function will be significantly greater using the active FES therapy than the passive FES therapy.
Aim 2: To investigate the relationship between brain functional activation patterns and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain fMRI and EEG measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.
Aim 3: To investigate the relationship between brain white matter integrity and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain DTI measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •New-onset ischemic stroke 12 months prior - chronic time frame;
- •Right hand dominant - affected arm;
- •Mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment;
- •No upper extremity injury or conditions that limited use prior to the stroke;
- •Must be able to provide informed consent on their own behalf.
Exclusion Criteria
- •Inability to competently participate in study procedures
- •Concurrent upper extremity therapy, other neurological or psychiatric disorders
Arms & Interventions
Passive FES
Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.
Intervention: Functional Electric Stimulation (FES) (Device)
Passive FES
Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.
Intervention: Behavioral Assessments (Behavioral)
Passive FES
Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.
Intervention: Magnetic Resonance Imaging (Other)
Active FES
Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.
Intervention: Functional Electric Stimulation (FES) (Device)
Active FES
Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.
Intervention: Behavioral Assessments (Behavioral)
Active FES
Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.
Intervention: Magnetic Resonance Imaging (Other)
Active FES
Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.
Intervention: EEG (Other)
Outcomes
Primary Outcomes
Action Research Arm Test Scores
Time Frame: baseline, 7 weeks, 10 weeks, 4 months
The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. Scores will be reported for baseline, mid (\~7 weeks), post (\~10 weeks), and end of study, up to 4 months.
Stroke Impact Scale
Time Frame: baseline, 7 weeks, 10 weeks, 4 months
The Stroke Impact Scale, or SIS, was created to assess changes in impairments, activities and participation following a stroke. Scores on the SIS will provide an index of clinically "meaningful" change representing the change in the patient's mental and physical abilities concurrent with their performance on the verbal fluency and memory tasks. The 4 physical function domains (strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), and mobility) will be collapsed to a physical function subscale. All domain scores range from 0 to 100 with 100 being the best.
Secondary Outcomes
- Change in Modified Ashworth Scale (MAS)(4 months)
- Change in Electroencephalogram (EEG) Response Strength(baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months)
- Signal Change in Functional Magnetic Resonance Imaging (MRI)(baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months)
- Nine Hole Peg Test (9HPT)(baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months)
- Motor Activity Log (MAL): Amount of Use(baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months)
- Motor Activity Log (MAL): Quality of Movement(baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months)
- Change in Modified Ashworth Scale (MAS)(4 months)
- Hand Grip Strength(baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months)
- Center for Epidemiologic Studies Depression Scale (CES-D)(4 months)