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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
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.
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
A functional magnetic resonance image will be collected.
University of Wisconsin
Madison, Wisconsin, United States
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.
Time frame: baseline, 7 weeks, 10 weeks, 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.
Time frame: baseline, 7 weeks, 10 weeks, 4 months
Change in Electroencephalogram (EEG) Response Strength
EEG was recorded in microvolts (µV) from electrodes C4/C3 during periods of left arm imagery and right arm imagery. EEG Response strength is defined as the spectral power in the mu + beta frequency band (8-30 Hz), averaged over the BCI trials. For each participant and time point, a ratio was computed: Ratio = Power\_Left Imagery / Power\_Right Imagery.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 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.
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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.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
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.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Motor Activity Log (MAL): Amount of Use
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. The Amount of Use scoring is as follows (intermediate scores are possible, 0.5 between each whole number): * 0 - Did not use my weaker arm (not used). * 1 - Occasionally used my weaker arm, but only very rarely (very rarely). * 2 - Sometimes used my weaker arm but did the activity most of the time with my stronger arm (rarely). * 3 - Used my weaker arm about half as much as before the stroke (half pre-stroke). * 4 - Used my weaker arm almost as much as before the stroke (3/4 pre-stroke). * 5 - Used my weaker arm as often as before the stroke (same as pre-stroke).
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Motor Activity Log (MAL): Quality of Movement
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. The Quality of Movement was scored as follows (intermediate scores 0.5 between whole numbers are possible): * 0 - The weaker arm was not used at all for that activity (never). * 1 - The weaker arm was moved during that activity but was not helpful (very poor). * 2 - The weaker arm was of some use during that activity but needed some help from the stronger arm or moved very slowly or with difficulty (poor). * 3 - The weaker arm was used for the purpose indicated but movements were slow or were made with only some effort (fair). * 4 - The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal). * 5 - The ability to use the weaker arm for that activity was as good as before the stroke (normal).
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 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.
Time frame: 4 months
Hand Grip Strength
Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
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.
Time frame: 4 months