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

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

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.

The BCI4STROKE-Arm clinical trial aims to demonstrate the proof of concept of innovative neurorehabilitation protocols in stroke patients based on the use of neuroprostheses. The objective is to define and evaluate rehabilitation protocols in chronic patients 6 to 18 months after a disabling stroke, promoting neuroplasticity processes through the use of the WIMAGINE neuroprosthesis and brain signal decoding algorithms. This brain-machine interface (BCI) based on the WIMAGINE electrocorticographic (ECoG) measurement implant will be used to control hand rehabilitation devices (functional electrical stimulation, robotic orthosis, and video observation therapy device) as part of the REHABCI system. Patients will follow a six-month intensive rehabilitation program (between three and five days per week) based on the use of this REHABCI system.

Inclusion Criteria:

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