Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

NCT04141774 | Completed Results FDA Device

• 5 other identifiers: 2018-09711R01NS105646-01A1A539300SMPH/RADIOLOGYProtocol Version 2/1/22
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

aneurysm; transient ischemic attack

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline, 7 weeks, 10 weeks, 4 months

Secondary Outcomes (8)

• Change in Electroencephalogram (EEG) Response Strength

  baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

• Signal Change in Functional Magnetic Resonance Imaging (MRI)

  baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

• Nine Hole Peg Test (9HPT)

  baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

• Motor Activity Log (MAL): Amount of Use

  baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

• Motor Activity Log (MAL): Quality of Movement

  baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

Study Arms (2)

Passive FES

ACTIVE COMPARATOR

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); Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging

Active FES

EXPERIMENTAL

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); Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging; Other: EEG

Interventions

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.

Active FES; Passive FES

Behavioral Assessments BEHAVIORAL

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

Active FES; Passive FES

Magnetic Resonance Imaging OTHER

A functional magnetic resonance image will be collected.

Active FES; Passive FES

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.

Also known as: Electroencephalography

Active FES

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to competently participate in study procedures
• Concurrent upper extremity therapy, other neurological or psychiatric disorders

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (5)

• Young BM, Stamm JM, Song J, Remsik AB, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Brain-Computer Interface Training after Stroke Affects Patterns of Brain-Behavior Relationships in Corticospinal Motor Fibers. Front Hum Neurosci. 2016 Sep 16;10:457. doi: 10.3389/fnhum.2016.00457. eCollection 2016.

  PMID: 27695404 RESULT

• Young BM, Nigogosyan Z, Walton LM, Remsik A, Song J, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Dose-response relationships using brain-computer interface technology impact stroke rehabilitation. Front Hum Neurosci. 2015 Jun 23;9:361. doi: 10.3389/fnhum.2015.00361. eCollection 2015.

  PMID: 26157378 RESULT

• Song J, Nair VA, Young BM, Walton LM, Nigogosyan Z, Remsik A, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. DTI measures track and predict motor function outcomes in stroke rehabilitation utilizing BCI technology. Front Hum Neurosci. 2015 Apr 27;9:195. doi: 10.3389/fnhum.2015.00195. eCollection 2015.

  PMID: 25964753 RESULT

• Song J, Young BM, Nigogosyan Z, Walton LM, Nair VA, Grogan SW, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. Characterizing relationships of DTI, fMRI, and motor recovery in stroke rehabilitation utilizing brain-computer interface technology. Front Neuroeng. 2014 Jul 29;7:31. doi: 10.3389/fneng.2014.00031. eCollection 2014.

  PMID: 25120466 RESULT

• Young BM, Nigogosyan Z, Nair VA, Walton LM, Song J, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Case report: post-stroke interventional BCI rehabilitation in an individual with preexisting sensorineural disability. Front Neuroeng. 2014 Jun 24;7:18. doi: 10.3389/fneng.2014.00018. eCollection 2014.

  PMID: 25009491 RESULT

Related Links

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MeSH Terms

Conditions

Stroke; Aneurysm; Ischemic Attack, Transient

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Vivek Prabhakaran, MD, PhD
• Organization: UW School of Medicine and Public Health

vprabhakaran@uwhealth.org

(608) 265-5269

Study Officials

• Vivek Prabhakaran, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 28, 2019
• Study Start: September 27, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)