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Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

Stroke Rehabilitation Using BCI Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04141774
Enrollment
84
Registered
2019-10-28
Start date
2018-09-27
Completion date
2024-12-31
Last updated
2025-11-04

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

Conditions

Stroke

Keywords

aneurysm, transient ischemic attack

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.

Interventions

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.

OTHERMagnetic Resonance Imaging

A functional magnetic resonance image will be collected.

OTHEREEG

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.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Action Research Arm Test Scoresbaseline, 7 weeks, 10 weeks, 4 monthsThe 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 Scalebaseline, 7 weeks, 10 weeks, 4 monthsThe 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

MeasureTime frameDescription
Nine Hole Peg Test (9HPT)baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsThe 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.
Motor Activity Log (MAL): Amount of Usebaseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsThe 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).
Motor Activity Log (MAL): Quality of Movementbaseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsThe 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).
Signal Change in Functional Magnetic Resonance Imaging (MRI)baseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsTo compare the percent signal change in the functional MRI activations before and after functional stimulation.
Hand Grip Strengthbaseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsHand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.
Center for Epidemiologic Studies Depression Scale (CES-D)4 monthsThe 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.
Change in Modified Ashworth Scale (MAS)4 monthsThe 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.
Change in Electroencephalogram (EEG) Response Strengthbaseline 1, baseline 2, 7 weeks, 10 weeks, 4 monthsEEG 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
42
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.
42
Total84

Baseline characteristics

CharacteristicPassive FESTotalActive FES
Age, Continuous67.38 years67.03 years66.67 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants83 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
40 Participants78 Participants38 Participants
Region of Enrollment
United States
42 participants84 participants42 participants
Sex: Female, Male
Female
18 Participants39 Participants21 Participants
Sex: Female, Male
Male
24 Participants45 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 42
other
Total, other adverse events
0 / 420 / 42
serious
Total, serious adverse events
0 / 420 / 42

Outcome results

Primary

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

Population: Some participants did not provide data for all time points.

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESAction Research Arm Test Scoresbaseline28.10 score on a scaleStandard Deviation 17.84
Passive FESAction Research Arm Test Scores7 weeks29.95 score on a scaleStandard Deviation 17.3
Passive FESAction Research Arm Test Scores10 weeks32.53 score on a scaleStandard Deviation 16.97
Passive FESAction Research Arm Test Scores4 months31.78 score on a scaleStandard Deviation 16.85
Active FESAction Research Arm Test Scores4 months34.10 score on a scaleStandard Deviation 18.57
Active FESAction Research Arm Test Scoresbaseline27.76 score on a scaleStandard Deviation 18.38
Active FESAction Research Arm Test Scores10 weeks32.83 score on a scaleStandard Deviation 18.6
Active FESAction Research Arm Test Scores7 weeks30.18 score on a scaleStandard Deviation 18.3
Primary

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

Population: Some participants did not provide data at all timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESStroke Impact Scale10 weeks69.97 score on a scaleStandard Deviation 22.64
Passive FESStroke Impact Scale4 months59.86 score on a scaleStandard Deviation 14.5
Passive FESStroke Impact Scale7 weeks70.29 score on a scaleStandard Deviation 19.81
Passive FESStroke Impact Scalebaseline61.90 score on a scaleStandard Deviation 24.68
Active FESStroke Impact Scale10 weeks67.35 score on a scaleStandard Deviation 21.24
Active FESStroke Impact Scale7 weeks68.22 score on a scaleStandard Deviation 22
Active FESStroke Impact Scale4 months78.49 score on a scaleStandard Deviation 14.61
Active FESStroke Impact Scalebaseline66.07 score on a scaleStandard Deviation 23.32
Secondary

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

Population: 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.

Secondary

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

Population: Some participants did not provide data at all time points

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESChange in Electroencephalogram (EEG) Response StrengthBaseline 20.855 ratioStandard Deviation 0.228
Passive FESChange in Electroencephalogram (EEG) Response Strength10 weeks0.957 ratioStandard Deviation 0.171
Passive FESChange in Electroencephalogram (EEG) Response Strength7 weeks0.970 ratioStandard Deviation 0.205
Passive FESChange in Electroencephalogram (EEG) Response Strength4 months1.125 ratioStandard Deviation 0.131
Passive FESChange in Electroencephalogram (EEG) Response StrengthBaseline 11.120 ratioStandard Deviation 0.119
Active FESChange in Electroencephalogram (EEG) Response Strength4 months1.228 ratioStandard Deviation 0.083
Active FESChange in Electroencephalogram (EEG) Response StrengthBaseline 10.882 ratioStandard Deviation 0.09
Active FESChange in Electroencephalogram (EEG) Response StrengthBaseline 21.145 ratioStandard Deviation 0.126
Active FESChange in Electroencephalogram (EEG) Response Strength7 weeks1.236 ratioStandard Deviation 0.113
Active FESChange in Electroencephalogram (EEG) Response Strength10 weeks1.328 ratioStandard Deviation 0.234
Secondary

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

Population: 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.

Secondary

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

Population: Some participants did not provide data at all timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESHand Grip Strengthbaseline 232.86 kilogramsStandard Deviation 19.01
Passive FESHand Grip Strength10 weeks37.45 kilogramsStandard Deviation 17.43
Passive FESHand Grip Strength7 weeks34.66 kilogramsStandard Deviation 18.11
Passive FESHand Grip Strength4 months37.37 kilogramsStandard Deviation 16.68
Passive FESHand Grip Strengthbaseline 132.95 kilogramsStandard Deviation 18.69
Active FESHand Grip Strength4 months38.68 kilogramsStandard Deviation 17.32
Active FESHand Grip Strengthbaseline 131.54 kilogramsStandard Deviation 18.61
Active FESHand Grip Strengthbaseline 231.10 kilogramsStandard Deviation 18.82
Active FESHand Grip Strength7 weeks34.78 kilogramsStandard Deviation 17.92
Active FESHand Grip Strength10 weeks37.29 kilogramsStandard Deviation 18.56
Secondary

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

Population: Some participants did not provide data at all timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESMotor Activity Log (MAL): Amount of Usebaseline 21.052 score on a scaleStandard Deviation 0.2902
Passive FESMotor Activity Log (MAL): Amount of Use10 weeks1.631 score on a scaleStandard Deviation 0.2813
Passive FESMotor Activity Log (MAL): Amount of Use7 weeks1.413 score on a scaleStandard Deviation 0.3252
Passive FESMotor Activity Log (MAL): Amount of Use4 months1.750 score on a scaleStandard Deviation 0.3137
Passive FESMotor Activity Log (MAL): Amount of Usebaseline 10.9888 score on a scaleStandard Deviation 0.3004
Active FESMotor Activity Log (MAL): Amount of Use4 months2.603 score on a scaleStandard Deviation 0.3151
Active FESMotor Activity Log (MAL): Amount of Usebaseline 11.280 score on a scaleStandard Deviation 0.3071
Active FESMotor Activity Log (MAL): Amount of Usebaseline 21.452 score on a scaleStandard Deviation 0.3665
Active FESMotor Activity Log (MAL): Amount of Use7 weeks1.750 score on a scaleStandard Deviation 0.2934
Active FESMotor Activity Log (MAL): Amount of Use10 weeks2.048 score on a scaleStandard Deviation 0.2766
Secondary

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

Population: Some participants did not provide data at all timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESMotor Activity Log (MAL): Quality of Movementbaseline 21.073 score on a scaleStandard Deviation 0.313
Passive FESMotor Activity Log (MAL): Quality of Movement10 weeks1.557 score on a scaleStandard Deviation 0.2645
Passive FESMotor Activity Log (MAL): Quality of Movement7 weeks1.363 score on a scaleStandard Deviation 0.36
Passive FESMotor Activity Log (MAL): Quality of Movement4 months1.854 score on a scaleStandard Deviation 0.2726
Passive FESMotor Activity Log (MAL): Quality of Movementbaseline 10.9564 score on a scaleStandard Deviation 0.2786
Active FESMotor Activity Log (MAL): Quality of Movement4 months2.541 score on a scaleStandard Deviation 0.348
Active FESMotor Activity Log (MAL): Quality of Movementbaseline 11.219 score on a scaleStandard Deviation 0.3305
Active FESMotor Activity Log (MAL): Quality of Movementbaseline 21.372 score on a scaleStandard Deviation 0.369
Active FESMotor Activity Log (MAL): Quality of Movement7 weeks1.846 score on a scaleStandard Deviation 0.2713
Active FESMotor Activity Log (MAL): Quality of Movement10 weeks2.164 score on a scaleStandard Deviation 0.3438
Secondary

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

Population: Some participants did not provide data at all time points.

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESNine Hole Peg Test (9HPT)Baseline visit 259.53 secondsStandard Deviation 4.629
Passive FESNine Hole Peg Test (9HPT)10 weeks59.07 secondsStandard Deviation 5.047
Passive FESNine Hole Peg Test (9HPT)7 weeks59.65 secondsStandard Deviation 3.681
Passive FESNine Hole Peg Test (9HPT)4 months58.15 secondsStandard Deviation 5.236
Passive FESNine Hole Peg Test (9HPT)Baseline visit 159.89 secondsStandard Deviation 4.78
Active FESNine Hole Peg Test (9HPT)4 months56.29 secondsStandard Deviation 3.935
Active FESNine Hole Peg Test (9HPT)Baseline visit 159.07 secondsStandard Deviation 4.656
Active FESNine Hole Peg Test (9HPT)Baseline visit 259.24 secondsStandard Deviation 4.676
Active FESNine Hole Peg Test (9HPT)7 weeks58.52 secondsStandard Deviation 5.066
Active FESNine Hole Peg Test (9HPT)10 weeks58.64 secondsStandard Deviation 5.565
Secondary

Signal Change in Functional Magnetic Resonance Imaging (MRI)

To compare the percent signal change in the functional MRI activations before and after functional stimulation.

Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

Population: Some participants did not provide data at all time points

ArmMeasureGroupValue (MEAN)Dispersion
Passive FESSignal Change in Functional Magnetic Resonance Imaging (MRI)Baseline 21.003 percent signal changeStandard Deviation 0.459
Passive FESSignal Change in Functional Magnetic Resonance Imaging (MRI)10 weeks1.117 percent signal changeStandard Deviation 0.581
Passive FESSignal Change in Functional Magnetic Resonance Imaging (MRI)7 weeks1.130 percent signal changeStandard Deviation 0.518
Passive FESSignal Change in Functional Magnetic Resonance Imaging (MRI)4 months1.121 percent signal changeStandard Deviation 0.423
Passive FESSignal Change in Functional Magnetic Resonance Imaging (MRI)Baseline 11.136 percent signal changeStandard Deviation 0.466
Active FESSignal Change in Functional Magnetic Resonance Imaging (MRI)4 months1.192 percent signal changeStandard Deviation 0.482
Active FESSignal Change in Functional Magnetic Resonance Imaging (MRI)Baseline 11.203 percent signal changeStandard Deviation 0.461
Active FESSignal Change in Functional Magnetic Resonance Imaging (MRI)Baseline 21.153 percent signal changeStandard Deviation 0.44
Active FESSignal Change in Functional Magnetic Resonance Imaging (MRI)7 weeks1.108 percent signal changeStandard Deviation 0.461
Active FESSignal Change in Functional Magnetic Resonance Imaging (MRI)10 weeks1.156 percent signal changeStandard Deviation 0.583

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026