An interventional study of Neurolutions IpsiHand Upper Extremity Rehabilitation System and Home Exercise rehabilitation regimen Program (HEP) in Stroke, Hemiparesis and Spasticity as Sequela of Stroke, sponsored by Neurolutions, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Neurolutions, Inc. · Not applicable, Interventional, and Treatment
BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.
After meeting the inclusion criteria, all participants underwent an EEG evaluation to ensure that EEG features sufficient for device control could be detected. Participants who met the inclusion/exclusion criteria and passed the EEG test were randomly assigned (1:1) to either home-based BCI rehabilitation (BCI) or a Home Exercise rehabilitation regimen Program (HEP).
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks. During the therapy sessions, the system would guide the patient through a series of routines in which they would imagine opening and closing their affected hand. At the instant the BCI detected sensorimotor cortex EEG spectral features associated with imagined ipsilateral hand movements, the handpiece opened and closed the participant's hand in a three-finger pinch grip.
Participants did not receive occupational or physical therapy services while participating in the self-directed BCI Therapy.
Participants allocated to the HEP control group received a structured home exercise program designed to control for non-specific motor and sensory engagement associated with the intervention. They completed an in-person baseline assessment of function and an HEP training session with an OT. The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
The Primary outcome assessment was the in-person Upper Extremity Fugl-Meyer (UEFM) completed on day 1 (baseline) and after 12 weeks of participation.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 109 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Neurolutions, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.
Device: Neurolutions IpsiHand Upper Extremity Rehabilitation System
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
Other: Home Exercise rehabilitation regimen Program (HEP)
Electroencephalography (EEG)-driven upper extremity powered exerciser. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
Upper Extremity Fugl-Meyer (UEFM)
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
Time frame: 12 weeks
| Milestone | Home Based BCI Rehabilitation (BCI) | Home Exercise Rehabilitation Regimen Program (HEP) |
|---|---|---|
| Started | 43 | 42 |
| Completed | 37 | 25 |
| Not completed | 6 | 17 |
| Withdrew: Protocol violation | 3 | 0 |
| Withdrew: Withdrawal by subject | 3 | 17 |
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
| Units on a scale | Home Based BCI Rehabilitation (BCI) | Home Exercise Rehabilitation Regimen Program (HEP) |
|---|---|---|
| Upper Extremity Fugl-Meyer (UEFM) | 32.6 ± 18.3 | 28.1 ± 16.6 |
Collected over From Baseline to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Based BCI Rehabilitation (BCI) | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Home Exercise Rehabilitation Regimen Program (HEP) | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
Per Analysis Set
| Age, Customized(Years) | Home Based BCI Rehabilitation (BCI) | Home Exercise Rehabilitation Regimen Program (HEP) | Total |
|---|---|---|---|
| Age | 58.1 ± 15.7 | 53.1 ± 16.6 | 56.4 ± 16.2 |
| Sex: Female, Male(Participants) | Home Based BCI Rehabilitation (BCI) | Home Exercise Rehabilitation Regimen Program (HEP) | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 24 | 14 | 38 |
| Race/Ethnicity, Customized(Participants) | Home Based BCI Rehabilitation (BCI) | Home Exercise Rehabilitation Regimen Program (HEP) | Total |
|---|---|---|---|
| White | 28 | 21 | 49 |
| Black | 4 | 2 | 6 |
| Asian | 1 | 1 | 2 |
| Other/Unknown | 4 | 1 | 5 |
| Upper Extremity Fugl-Meyer(Units on a scale) | Home Based BCI Rehabilitation (BCI) | Home Exercise Rehabilitation Regimen Program (HEP) | Total |
|---|---|---|---|
| Mean | 26.3 ± 17.9 | 26.7 ± 14.4 | 26.5 ± 16.4 |
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