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

Ki vehet részt

• 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

Ki nem vehet részt

• 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)