Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBCI
WIMAGINE
Sponsors
University Hospital, Grenoble
French Alternative Energies and Atomic Energy Commission (CEA), Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective, proof-of-concept, multicenter, open-label study of feasibility and safety.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of a wireless ECoG-based BCI using WIMAGINE® system in stroke patients | 2 years after surgery | Serious adverse events associated with the chronic implantation of an extradural ECoG measuring implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the task-oriented rehabilitation program using brain- controlled devices to perform daily life movements | 7 months after surgery | Increase in motricity and functional movements of the patient, utilizing assessments such as the Fugl- Meyer Assessment for Upper Extremity (FMA-UE), the Action Research Arm Test (ARAT), the Box and Block Test (BBT) and Range of Motion (RoM) |
Countries
France
Contacts
CONTACTOlivier DETANTE, MD, PhD
CONTACTCaroline SANDRE-BALLESTER, PhD
Outcome results
None listed