Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

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.

Official Title
-----------------
Stroke Rehabilitation Using BCI Technology

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Functional Electric Stimulation (FES)
* Behavioral: Behavioral Assessments
* Other: Magnetic Resonance Imaging
* Other: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Passive FES<br>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. | Device: Functional Electric Stimulation (FES)<br>* FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.<br>Behavioral: Behavioral Assessments<br>* These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.<br>Other: Magnetic Resonance Imaging<br>* A functional magnetic resonance image will be collected.<br>|
| Experimental: Active FES<br>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. | Device: Functional Electric Stimulation (FES)<br>* FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.<br>Behavioral: Behavioral Assessments<br>* These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.<br>Other: Magnetic Resonance Imaging<br>* A functional magnetic resonance image will be collected.<br>Other: EEG<br>* EEG electrodes will be attached to the subject's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.<br>* Other names: Electroencephalography;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test Scores | 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. | 4 months | 
| Stroke Impact Scale | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Electroencephalogram (EEG) Response Strength | The change in the strength of the EEG response before and after functional stimulation during left arm imagery with respect to right arm imagery. | 4 months | 
| Signal Change in Functional Magnetic Resonance Imaging (MRI) | To compare the percent signal change in the functional MRI activations before and after functional stimulation. | 4 months | 
| Change in Nine Hole Peg Test (9HPT) | The 9-HPT is a quick and easy to administer tool for screening fine motor problems in participants. It is a timed test in which nine pegs are inserted and removed from nine holes in the pegboard with each hand. Measured at 5 time points over the length of the study. | 4 months | 
| Change in Motor Activity Log (MAL) | The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. | 4 months | 
| Change in Modified Ashworth Scale (MAS) | The MAS measures spasticity where 0 is no increase in muscle tone to 4 where affected part is in rigid in flexion or extension. Assessed at 5 time points over the length of the study. | 4 months | 
| Change in Hand Grip Strength | Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study. | 4 months | 
| Change in Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a self-report scale and includes 20 items that survey mood, somatic complaints, interactions with others, and motor functioning in the past week. Total possible score 0-60, with the higher score indicating more symptoms of depression. Assessed at 5 time points over the length of the study. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneurysm, transient ischemic attack