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

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