About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Contraindication for general anesthesia and for the surgery (such as thrombocytopenia, …)
Severe leukoaraiosis
Trial design
Treatments tested in this trial
- BCI
Treatment groups
Sponsors and collaborators
University Hospital, Grenoble
Lead sponsor
French Alternative Energies and Atomic Energy Commission (CEA), Grenoble
Collaborator