Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

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 typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment10 (estimated)
SponsorUniversity Hospital, Grenoble
Academic / other
Locations1 site (Grenoble)
StatusRecruiting
StartedApril 8, 2026
Main results expectedApril 8, 2029
Study endsApril 8, 2031
Registry record updatedJuly 7, 2026
Trial IDNCT07477613 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.