Brain-brain interface to aid arm recovery after stroke
Official title: Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke
Run by University Hospital, Grenoble · NCT07477613 · Data updated 2026-11-12
This study tests a brain-computer interface-guided rehabilitation to help people regain upper-limb movement after a stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Status | Recruiting |
| Started | April 8, 2026 |
| Main results expected | April 8, 2029 |
| Study ends | April 8, 2031 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07477613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with a unilateral ischemic stroke 6–18 months prior, with disabling upper-limb impairment and the ability to participate in rehabilitation.
✕Probably not a fit
Patients without suitable anatomy for the implant or those unable to complete a six-month intensive program may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial investigates a neurorehabilitation approach using a brain-machine interface (BCI) with the WIMAGINE ECoG implant to control hand rehabilitation devices during a six-month intensive program for chronic stroke patients. It includes a pre-selection phase to confirm suitability, a rehab phase comparing traditional therapy to BCI-assisted therapy, and a follow-up phase to monitor implant longevity and motor gains. Participants will engage in 3–5 sessions per week for six months, with devices such as functional electrical stimulation, robotic orthosis, and video observation tools as part of the REHABCI system. The study aims to establish proof of concept for BCI-based neurorehabilitation and define protocols for promoting neuroplasticity in post-stroke patients.
Why it matters
Potential benefit: If successful, patients may experience greater restoration of hand function and improved quality of life through enhanced neuroplasticity and more effective rehabilitation.
How similar studies have gone: Previous studies in neuroprosthesis and BCI-assisted rehabilitation have shown proof of concept; this trial builds on those approaches in a chronic-stroke population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, 18-70 years-old included 2. Hemispheric ischemic stroke (\> 1.5 cm on 2 imaging slices): cortical and/or subcortical lesion 3. No decompressive craniectomy procedure performed 4. Single unilateral stroke occurred 6 months to 18 months ago 5. Disabling motor deficit of upper limb 6. Patient able to follow a rehabilitation program 7. Written consent to participate in the study from the patient and his/her legal representative 8. Person affiliated to the social security system or beneficiary of such a system 9. Highly effective or at least acceptable birth control method for women of childbearing potential Exclusion Criteria: 1. Contraindication for Magnetic Resonance Imaging (MRI), Computed Tomography (CT-scan), Positron Emission Tomography (PET-scan) 2. Contraindication for Transcranial Magnetic Stimulation (TMS), Electroencephalography (EEG), Magnetoencephalography (MEG) 3. Contraindication for general anesthesia and for the surgery (such as thrombocytopenia, …) 4. Severe leukoaraiosis 5. Previous stroke (symptomatic deficit) 6. Pre-existing dementia or significant cognitive deficits (MoCA) 7. Intolerance to electrical stimulation 8. Major spasticity in the upper limb (4 or 5 in the scale of Modified Ashworth Scale - MAS) 9. Lesions on the scalp area, skin infections or dermatitis 10. Epileptiform focus, even without clinical repercussions 11. A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial 12. Presence of brain implants of metal clips and/or brain stimulators 13. Severe dystonia/involuntary movements Patients with any of the following criteria cannot be included in this investigation: 1. Contraindication for MRI, CT-scan, PET-scan 2. Contraindication for TMS, EEG, MEG 3. Contraindication for general anesthesia and for the surgery (such as thrombocytopenia, …) 4. Severe leukoaraiosis 5. Previous stroke (symptomatic deficit) 6. Pre-existing dementia or significant cognitive deficits (MoCA) 7. Intolerance to electrical stimulation 8. Major spasticity in the upper limb (4 or 5 in the scale of Modified Ashworth Scale - MAS) 9. Lesions on the scalp area, skin infections or dermatitis 10. Epileptiform focus, even without clinical repercussions 11. A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial 12. Presence of brain implants of metal clips and/or brain stimulators 13. Severe dystonia/involuntary movements 14. Persons referred to in Articles L1121-5 to L1121-7 of the French Public Health Code (CSP), corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, individuals undergoing psychiatric care under Articles L.3212-1 and L.3213-1 who are not covered by Article L.1121-8, individuals admitted to a healthcare or social institution for purposes other than research, and minors. Moreover, patient will not be included for implantation (exclusion criteria), if he is not eligible for a BCI rehabilitation protocol, as determined by the clinical team after multimodal selection tests. As examples, it can be due to: 1. No existing residual corticospinal tracts proven tractography and/or Motor Evoked Potential (MEP) 2. Unability to control a BCI or unwillingness to follow a BCI rehabilitation program, assessed by MEG-BCI 3. Unability to activate any residual motor regions during motor imagery assessed by EEG and functional MRI (fMRI) 4. Shape of the skull in the implantation site not concordant with the WIMAGINE implant, assessed by anatomical MRI
Where it's running
-
Chuga
Grenoble, France Recruiting
Study contacts
- Study coordinator: Olivier DETANTE, MD, PhD
- Email: ODetante@chu-grenoble.fr
- Phone: 04 76 76 57 89
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
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Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.