StrokeNCT05965713
Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
A study testing Neurolutions IpsiHand Upper Extremity Rehabilitation System and Home Exercise rehabilitation regimen Program (HEP) in people with Stroke and Hemiparesis, run by Neurolutions, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis, Spasticity as Sequela of Stroke
- What is being tested?
- Neurolutions IpsiHand Upper Extremity Rehabilitation System and Home Exercise rehabilitation regimen Program (HEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age (18-85)
- Adults who sustained a CVA
- Have upper extremity hemiparesis/hemiplegia
- Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
Who cannot join
- Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
- Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.
- Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
- Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.
- Participants receiving any formal upper extremity therapy will be excluded.
- Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
- Participants who are pregnant or breast-feeding will be excluded.
- Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Stroke, Hemiparesis, Spasticity as Sequela of Stroke, Brain Computer Interface, Chronic Stroke Survivors With Plegic Hand
- Being tested
- Neurolutions IpsiHand Upper Extremity Rehabilitation System, Home Exercise rehabilitation regimen Program (HEP)
- Keywords
- Neurolutions, IpsiHand
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurolutions IpsiHand Upper Extremity Rehabilitation SystemDevice
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.
Home Exercise rehabilitation regimen Program (HEP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Based BCI Rehabilitation (BCI) | Experimental | 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. Receives: Device: Neurolutions IpsiHand Upper Extremity Rehabilitation System |
| Home Exercise rehabilitation regimen Program (HEP) | Active comparator | 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. Receives: Other: Home Exercise rehabilitation regimen Program (HEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer (UEFM)
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Oct 2023
- Primary completion12 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Randomization
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alexandre Carter, MD, PhD, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965713
- Sponsor's protocol ID
- BCI-REHAB
- Other IDs
- 4R44HD105579-02
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2023
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data Supplement is available upon written request per NIH guidelines.
Publications
Leuthardt EC, Wilk SJ, Souders L, Carr KB, Coker R, Wilding GE, Zuleger D, Acland BT, Carter AR. At-Home BCI Rehabilitation Therapy for Chronic Upper Extremity Deficit After Stroke (BCI-REHAB): A Randomized Trial. Stroke Vasc Interv Neurol. 2026 Aug 13;6(5):e002345. doi: 10.1161/SVIN.126.002345. eCollection 2026 Sep.
PubMed 42708130
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05965713
- Acronym / sponsor ID
- BCI-REHAB
- Conditions
- Stroke, Hemiparesis, Spasticity as Sequela of Stroke, Brain Computer Interface, Chronic Stroke Survivors With Plegic Hand
- Keywords
- Neurolutions, IpsiHand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Neurolutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Randomization
| Arm | Type | Receives |
|---|---|---|
| Home Based BCI Rehabilitation (BCI) | Experimental | Device: Neurolutions IpsiHand Upper Extremity Rehabilitation SystemParticipants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks. |
| Home Exercise rehabilitation regimen Program (HEP) | Active comparator | Other: Home Exercise rehabilitation regimen Program (HEP)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age (18-85)
- Adults who sustained a CVA
- Have upper extremity hemiparesis/hemiplegia
- Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
Key exclusion criteria (8 listed)
- Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
- Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.
- Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
- Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.
- Participants receiving any formal upper extremity therapy will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurolutions IpsiHand Upper Extremity Rehabilitation SystemElectroencephalography (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. | Device | Home Based BCI Rehabilitation (BCI) |
| Home Exercise rehabilitation regimen Program (HEP)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) |
Primary outcome
Upper Extremity Fugl-Meyer (UEFM)
Time frame: 12 weeks
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42708130Leuthardt EC, Wilk SJ, Souders L, Carr KB, Coker R, Wilding GE, Zuleger D, Acland BT, Carter AR. At-Home BCI Rehabilitation Therapy for Chronic Upper Extremity Deficit After Stroke (BCI-REHAB): A Randomized Trial. Stroke Vasc Interv Neurol. 2026 Aug 13;6(5):e002345. doi: 10.1161/SVIN.126.002345. eCollection 2026 Sep.
- Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke SurvivorsLink provided by the sponsor.
- Using ipsilateral motor signals in the unaffected cerebral hemisphere as a signal platform for brain-computer interfaces in hemiplegic stroke survivorsLink provided by the sponsor.
- A retrospective analysis of post-stroke rehabilitation with real world use of brain-computer interfaceLink provided by the sponsor.
- Upper limb motor recovery in chronic stroke-longitudinal aggregate analysis from control group outcomesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data Supplement is available upon written request per NIH guidelines.
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Carter, MD, PhD principal investigator
Washington University in Saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolutions IpsiHand Upper Extremity Rehabilitation System and Home Exercise rehabilitation regimen Program (HEP) in people with Stroke and Hemiparesis, run by Neurolutions, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugl-Meyer (UEFM) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.