Trial Outcomes & Findings for Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology (NCT NCT04141774)
NCT ID: NCT04141774
Last Updated: 2025-11-04
Results Overview
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.
COMPLETED
NA
84 participants
baseline, 7 weeks, 10 weeks, 4 months
2025-11-04
Participant Flow
Participant milestones
| Measure |
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.
Functional Electric Stimulation (FES): 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.
Behavioral Assessments: These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
Magnetic Resonance Imaging: A functional magnetic resonance image will be collected.
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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.
Functional Electric Stimulation (FES): 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.
Behavioral Assessments: These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
Magnetic Resonance Imaging: A functional magnetic resonance image will be collected.
EEG: 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.
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|---|---|---|
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Overall Study
STARTED
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42
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42
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|
Overall Study
Baseline 1 (Pre-intervention)
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42
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42
|
|
Overall Study
Baseline 2 (Pre-intervention, Approximately 1 Month From Baseline 1)
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42
|
42
|
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Overall Study
7 Weeks (Mid-intervention)
|
41
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40
|
|
Overall Study
10 Weeks (End of Intervention)
|
40
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42
|
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Overall Study
4 Months (Post-intervention)
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41
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41
|
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Overall Study
COMPLETED
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42
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42
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology
Baseline characteristics by cohort
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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Total
n=84 Participants
Total of all reporting groups
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|---|---|---|---|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=15 Participants
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0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
2 Participants
n=161 Participants
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2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=15 Participants
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2 Participants
n=161 Participants
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4 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
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40 Participants
n=15 Participants
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38 Participants
n=161 Participants
|
78 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=15 Participants
|
21 Participants
n=161 Participants
|
45 Participants
n=100 Participants
|
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Age, Continuous
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67.38 years
n=15 Participants
|
66.67 years
n=161 Participants
|
67.03 years
n=100 Participants
|
|
Sex: Female, Male
Female
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18 Participants
n=15 Participants
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21 Participants
n=161 Participants
|
39 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=15 Participants
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1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=15 Participants
|
41 Participants
n=161 Participants
|
83 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
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Region of Enrollment
United States
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42 participants
n=15 Participants
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42 participants
n=161 Participants
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84 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: baseline, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data for all time points.
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.
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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|---|---|---|
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Action Research Arm Test Scores
baseline
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28.10 score on a scale
Standard Deviation 17.84
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27.76 score on a scale
Standard Deviation 18.38
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Action Research Arm Test Scores
7 weeks
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29.95 score on a scale
Standard Deviation 17.30
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30.18 score on a scale
Standard Deviation 18.30
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Action Research Arm Test Scores
10 weeks
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32.53 score on a scale
Standard Deviation 16.97
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32.83 score on a scale
Standard Deviation 18.60
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Action Research Arm Test Scores
4 months
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31.78 score on a scale
Standard Deviation 16.85
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34.10 score on a scale
Standard Deviation 18.57
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PRIMARY outcome
Timeframe: baseline, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all timepoints.
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.
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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|---|---|---|
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Stroke Impact Scale
baseline
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61.90 score on a scale
Standard Deviation 24.68
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66.07 score on a scale
Standard Deviation 23.32
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Stroke Impact Scale
7 weeks
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70.29 score on a scale
Standard Deviation 19.81
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68.22 score on a scale
Standard Deviation 22.00
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Stroke Impact Scale
10 weeks
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69.97 score on a scale
Standard Deviation 22.64
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67.35 score on a scale
Standard Deviation 21.24
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Stroke Impact Scale
4 months
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59.86 score on a scale
Standard Deviation 14.50
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78.49 score on a scale
Standard Deviation 14.61
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SECONDARY outcome
Timeframe: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all time points
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.
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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|---|---|---|
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Change in Electroencephalogram (EEG) Response Strength
10 weeks
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0.957 ratio
Standard Deviation 0.171
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1.328 ratio
Standard Deviation 0.234
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Change in Electroencephalogram (EEG) Response Strength
4 months
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1.125 ratio
Standard Deviation 0.131
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1.228 ratio
Standard Deviation 0.083
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Change in Electroencephalogram (EEG) Response Strength
Baseline 2
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0.855 ratio
Standard Deviation 0.228
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1.145 ratio
Standard Deviation 0.126
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Change in Electroencephalogram (EEG) Response Strength
7 weeks
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0.970 ratio
Standard Deviation 0.205
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1.236 ratio
Standard Deviation 0.113
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Change in Electroencephalogram (EEG) Response Strength
Baseline 1
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1.120 ratio
Standard Deviation 0.119
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0.882 ratio
Standard Deviation 0.090
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SECONDARY outcome
Timeframe: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all time points
To compare the percent signal change in the functional MRI activations before and after functional stimulation.
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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|---|---|---|
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Signal Change in Functional Magnetic Resonance Imaging (MRI)
Baseline 1
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1.136 percent signal change
Standard Deviation 0.466
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1.203 percent signal change
Standard Deviation 0.461
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Signal Change in Functional Magnetic Resonance Imaging (MRI)
Baseline 2
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1.003 percent signal change
Standard Deviation 0.459
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1.153 percent signal change
Standard Deviation 0.440
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Signal Change in Functional Magnetic Resonance Imaging (MRI)
7 weeks
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1.130 percent signal change
Standard Deviation 0.518
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1.108 percent signal change
Standard Deviation 0.461
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Signal Change in Functional Magnetic Resonance Imaging (MRI)
10 weeks
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1.117 percent signal change
Standard Deviation 0.581
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1.156 percent signal change
Standard Deviation 0.583
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Signal Change in Functional Magnetic Resonance Imaging (MRI)
4 months
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1.121 percent signal change
Standard Deviation 0.423
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1.192 percent signal change
Standard Deviation 0.482
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SECONDARY outcome
Timeframe: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all time points.
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.
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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Nine Hole Peg Test (9HPT)
Baseline visit 1
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59.89 seconds
Standard Deviation 4.780
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59.07 seconds
Standard Deviation 4.656
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Nine Hole Peg Test (9HPT)
Baseline visit 2
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59.53 seconds
Standard Deviation 4.629
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59.24 seconds
Standard Deviation 4.676
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Nine Hole Peg Test (9HPT)
7 weeks
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59.65 seconds
Standard Deviation 3.681
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58.52 seconds
Standard Deviation 5.066
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Nine Hole Peg Test (9HPT)
10 weeks
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59.07 seconds
Standard Deviation 5.047
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58.64 seconds
Standard Deviation 5.565
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Nine Hole Peg Test (9HPT)
4 months
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58.15 seconds
Standard Deviation 5.236
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56.29 seconds
Standard Deviation 3.935
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SECONDARY outcome
Timeframe: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all timepoints.
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).
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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|---|---|---|
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Motor Activity Log (MAL): Amount of Use
baseline 1
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0.9888 score on a scale
Standard Deviation 0.3004
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1.280 score on a scale
Standard Deviation 0.3071
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Motor Activity Log (MAL): Amount of Use
baseline 2
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1.052 score on a scale
Standard Deviation 0.2902
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1.452 score on a scale
Standard Deviation 0.3665
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Motor Activity Log (MAL): Amount of Use
7 weeks
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1.413 score on a scale
Standard Deviation 0.3252
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1.750 score on a scale
Standard Deviation 0.2934
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Motor Activity Log (MAL): Amount of Use
10 weeks
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1.631 score on a scale
Standard Deviation 0.2813
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2.048 score on a scale
Standard Deviation 0.2766
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Motor Activity Log (MAL): Amount of Use
4 months
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1.750 score on a scale
Standard Deviation 0.3137
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2.603 score on a scale
Standard Deviation 0.3151
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SECONDARY outcome
Timeframe: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all timepoints.
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).
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
|
|---|---|---|
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Motor Activity Log (MAL): Quality of Movement
baseline 1
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0.9564 score on a scale
Standard Deviation 0.2786
|
1.219 score on a scale
Standard Deviation 0.3305
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Motor Activity Log (MAL): Quality of Movement
baseline 2
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1.073 score on a scale
Standard Deviation 0.3130
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1.372 score on a scale
Standard Deviation 0.3690
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Motor Activity Log (MAL): Quality of Movement
7 weeks
|
1.363 score on a scale
Standard Deviation 0.3600
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1.846 score on a scale
Standard Deviation 0.2713
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Motor Activity Log (MAL): Quality of Movement
10 weeks
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1.557 score on a scale
Standard Deviation 0.2645
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2.164 score on a scale
Standard Deviation 0.3438
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Motor Activity Log (MAL): Quality of Movement
4 months
|
1.854 score on a scale
Standard Deviation 0.2726
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2.541 score on a scale
Standard Deviation 0.3480
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SECONDARY outcome
Timeframe: 4 monthsPopulation: MAS data were not collected in order to reduce participant burden associated with completing multiple assessments during study visits. The protocol was not amended to reflect this.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsPopulation: Some participants did not provide data at all timepoints.
Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.
Outcome measures
| Measure |
Passive FES
n=42 Participants
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.
|
Active FES
n=42 Participants
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.
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|---|---|---|
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Hand Grip Strength
baseline 1
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32.95 kilograms
Standard Deviation 18.69
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31.54 kilograms
Standard Deviation 18.61
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Hand Grip Strength
baseline 2
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32.86 kilograms
Standard Deviation 19.01
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31.10 kilograms
Standard Deviation 18.82
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Hand Grip Strength
7 weeks
|
34.66 kilograms
Standard Deviation 18.11
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34.78 kilograms
Standard Deviation 17.92
|
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Hand Grip Strength
10 weeks
|
37.45 kilograms
Standard Deviation 17.43
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37.29 kilograms
Standard Deviation 18.56
|
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Hand Grip Strength
4 months
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37.37 kilograms
Standard Deviation 16.68
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38.68 kilograms
Standard Deviation 17.32
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SECONDARY outcome
Timeframe: 4 monthsPopulation: CES-D data were not collected in order to reduce participant burden associated with completing multiple assessments during study visits. The protocol was not amended to reflect this.
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.
Outcome measures
Outcome data not reported
Adverse Events
Passive FES
Active FES
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vivek Prabhakaran, MD, PhD
UW School of Medicine and Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place