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Completed

NCT Number: NCT04141774

Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Electric Stimulation (FES)

Device

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

Behavioral

These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.

Magnetic Resonance Imaging

Other

A functional magnetic resonance image will be collected.

EEG

Other

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.

Other names: Electroencephalography

Primary outcomes

  1. 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.

  2. 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

  1. Change in Electroencephalogram (EEG) Response Strength

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

    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.

  2. Signal Change in Functional Magnetic Resonance Imaging (MRI)

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

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

  3. Nine Hole Peg Test (9HPT)

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

    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. Motor Activity Log (MAL): Amount of Use

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

    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).
  5. Motor Activity Log (MAL): Quality of Movement

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

    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).
  6. Change in Modified Ashworth Scale (MAS)

    Time frame: 4 months

    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.

  7. Hand Grip Strength

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

    Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Stroke Rehabilitation Using BCI Technology

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2019
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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