N/A
N=84
Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04141774 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Action Research Arm Test Scores — 28.10; 27.76; 29.95; 30.18 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional Electric Stimulation (FES) (Device); Behavioral Assessments (Behavioral); Magnetic Resonance Imaging (Other); EEG (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Action Research Arm Test Scores |
28.10; 27.76; 29.95; 30.18; 32.53; 32.83 | — |
| PRIMARY Stroke Impact Scale |
61.90; 66.07; 70.29; 68.22; 69.97; 67.35 | — |
| SECONDARY Change in Electroencephalogram (EEG) Response Strength |
1.120; 0.882; 0.855; 1.145; 0.970; 1.236 | — |
| SECONDARY Signal Change in Functional Magnetic Resonance Imaging (MRI) |
1.136; 1.203; 1.003; 1.153; 1.130; 1.108 | — |
| SECONDARY Nine Hole Peg Test (9HPT) |
59.89; 59.07; 59.53; 59.24; 59.65; 58.52 | — |
| SECONDARY Motor Activity Log (MAL): Amount of Use |
0.9888; 1.280; 1.052; 1.452; 1.413; 1.750 | — |
| SECONDARY Motor Activity Log (MAL): Quality of Movement |
0.9564; 1.219; 1.073; 1.372; 1.363; 1.846 | — |
| SECONDARY Change in Modified Ashworth Scale (MAS) |
— | — |
| SECONDARY Hand Grip Strength |
32.95; 31.54; 32.86; 31.10; 34.66; 34.78 | — |
| SECONDARY Center for Epidemiologic Studies Depression Scale (CES-D) |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04141774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.