Implanted Brain-Computer Interface to Help Arm Recovery After Stroke
Tests an implanted brain-computer interface during arm rehabilitation in adults after stroke.
Plain-language title generated from the registry record
Registry title: Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke
Key facts
- Where
- Grenoble, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07477613, who can take part
Where in France
- CHUGAGrenoble, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT07477613
- Record updated
- 7 July 2026
- Original description
The clinical investigation will take place in three phases:Read full original descriptionShow less
Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke
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.
Inclusion: 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.
Exclusion: 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; 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:; 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).