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

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT07477613

Run by

University Hospital, Grenoble

People needed

10

Starts

2026-04-08

Expected to finish

2031-04-08

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Previous stroke (symptomatic deficit)
• Pre-existing dementia or significant cognitive deficits (MoCA)
• Intolerance to electrical stimulation
• Major spasticity in the upper limb (4 or 5 in the scale of Modified Ashworth Scale - MAS)
• Lesions on the scalp area, skin infections or dermatitis
• Epileptiform focus, even without clinical repercussions
• 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
• Presence of brain implants of metal clips and/or brain stimulators
• 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
• Contraindication for general anesthesia and for the surgery (such as thrombocytopenia, …)
• Severe leukoaraiosis
• Previous stroke (symptomatic deficit)
• Pre-existing dementia or significant cognitive deficits (MoCA)
• Intolerance to electrical stimulation
• Major spasticity in the upper limb (4 or 5 in the scale of Modified Ashworth Scale - MAS)
• Lesions on the scalp area, skin infections or dermatitis
• Epileptiform focus, even without clinical repercussions
• 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

Where it is running

• CHUGA — Grenoble, France (enrolling)

Full record on ClinicalTrials.gov

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