Fact CheckerSign in

NCT07477613Recruiting

Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

The clinical investigation will take place in three phases: * A pre-selection/selection phase to ensure that the patient (lesion, symptoms, ability of our tools to detect your movement intentions, etc.) is suitable for a six-month intensive rehabilitation program using Brain-Machine Interface. * A second phase, consisting of implementing the intensive rehabilitation program, first in the traditional manner, without the Brain-Machine Interface (2 to 5 weeks), then, after implantation, with the Brain-Machine Interface (6 months). * During the third phase, only follow-up visits will be scheduled to ensure the longevity of the implants and the maintenance of the motor progress achieved through rehabilitation.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
24 Feb 2026
Start date
8 Apr 2026
Primary completion date
8 Apr 2029
Lead sponsor
University Hospital, Grenoble
Diseases
Stroke
NCT number
NCT07477613

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 8 Apr 2026 to the primary completion date, 8 Apr 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication for general anesthesia and for the surgery (such as thrombocytopenia, …)
  • Previous stroke (symptomatic deficit)
  • Presence of brain implants of metal clips and/or brain stimulators
  • Contraindication for general anesthesia and for the surgery (such as thrombocytopenia, …)
  • Previous stroke (symptomatic deficit)
  • Presence of brain implants of metal clips and/or brain stimulators
  • Shape of the skull in the implantation site not concordant with the WIMAGINE implant, assessed by anatomical MRI

Other illness

  • Pre-existing dementia or significant cognitive deficits (MoCA)
  • Lesions on the scalp area, skin infections or dermatitis
  • 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
  • Pre-existing dementia or significant cognitive deficits (MoCA)
  • Lesions on the scalp area, skin infections or dermatitis
  • 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
  • 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:

Other

  • Contraindication for Magnetic Resonance Imaging (MRI), Computed Tomography (CT-scan), Positron Emission Tomography (PET-scan)
  • Contraindication for Transcranial Magnetic Stimulation (TMS), Electroencephalography (EEG), Magnetoencephalography (MEG)
  • Severe leukoaraiosis
  • Intolerance to electrical stimulation
  • Major spasticity in the upper limb (4 or 5 in the scale of Modified Ashworth Scale - MAS)
  • Epileptiform focus, even without clinical repercussions
  • Severe dystonia/involuntary movements
    • Patients with any of the following criteria cannot be included in this investigation:
  • Contraindication for MRI, CT-scan, PET-scan
  • Contraindication for TMS, EEG, MEG
  • Severe leukoaraiosis
  • Intolerance to electrical stimulation
  • Major spasticity in the upper limb (4 or 5 in the scale of Modified Ashworth Scale - MAS)
  • Epileptiform focus, even without clinical repercussions
  • Severe dystonia/involuntary movements
  • No existing residual corticospinal tracts proven tractography and/or Motor Evoked Potential (MEP)
  • Unability to control a BCI or unwillingness to follow a BCI rehabilitation program, assessed by MEG-BCI
  • Unability to activate any residual motor regions during motor imagery assessed by EEG and functional MRI (fMRI)

Who the study is looking for

  • Male or female, 18-70 years-old included
  • Hemispheric ischemic stroke (\> 1.5 cm on 2 imaging slices): cortical and/or subcortical lesion
  • No decompressive craniectomy procedure performed
  • Single unilateral stroke occurred 6 months to 18 months ago
  • Disabling motor deficit of upper limb
  • Patient able to follow a rehabilitation program
  • Written consent to participate in the study from the patient and his/her legal representative
  • Person affiliated to the social security system or beneficiary of such a system
  • Highly effective or at least acceptable birth control method for women of childbearing potential

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHUGA
Coordinator of this site? Confirm its status		GrenobleFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.