Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

University of Wisconsin (UW)

Status: Completed

Conditions: Stroke

Treatments: Other: Magnetic Resonance Imaging; Other: EEG; Device: Functional Electric Stimulation (FES); Behavioral: Behavioral Assessments

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04141774

SMPH/RADIOLOGY (Other Identifier)

2018-0971

Protocol Version 2/1/22 (Other Identifier)

A539300 (Other Identifier)

1R01NS105646-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Passive FES

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Assessments

Device: Functional Electric Stimulation (FES)

Other: Magnetic Resonance Imaging

Active FES

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Assessments

Device: Functional Electric Stimulation (FES)

Other: EEG

Other: Magnetic Resonance Imaging