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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Grenoble

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

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Grenoble

Lead sponsor

French Alternative Energies and Atomic Energy Commission (CEA), Grenoble

Collaborator