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

NCT07477613 | Not Yet Recruiting DMC

• 1 other identifier: 2025-A01906-43 38RC25.0185
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Safety of a wireless ECoG-based BCI using WIMAGINE® system in stroke patients

  Serious adverse events associated with the chronic implantation of an extradural ECoG measuring implant

  2 years after surgery

Secondary Outcomes (1)

• Efficacy of the task-oriented rehabilitation program using brain- controlled devices to perform daily life movements

  7 months after surgery

Study Arms (1)

REHABCI System

EXPERIMENTAL

WIMAGINE-based upper-limb neurorehabilitation therapy

Device: BCI

Interventions

BCI DEVICE

WIMAGINE

REHABCI System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• French Alternative Energies and Atomic Energy Commission (CEA), Grenoble: collaborator

Related Publications (3)

• Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.

  PMID: 31587955 BACKGROUND

• Mestais CS, Charvet G, Sauter-Starace F, Foerster M, Ratel D, Benabid AL. WIMAGINE: wireless 64-channel ECoG recording implant for long term clinical applications. IEEE Trans Neural Syst Rehabil Eng. 2015 Jan;23(1):10-21. doi: 10.1109/TNSRE.2014.2333541. Epub 2014 Jun 30.

  PMID: 25014960 BACKGROUND

• Eliseyev A, Mestais C, Charvet G, Sauter F, Abroug N, Arizumi N, Cokgungor S, Costecalde T, Foerster M, Korczowski L, Moriniere B, Porcherot J, Pradal J, Ratel D, Tarrin N, Torres-Martinez N, Verney A, Aksenova T, Benabid AL. CLINATEC(R) BCI platform based on the ECoG-recording implant WIMAGINE(R) and the innovative signal-processing: preclinical results. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1222-5. doi: 10.1109/EMBC.2014.6943817.

  PMID: 25570185 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Olivier DETANTE, MD, PhD

CONTACT

04 76 76 57 89; ODetante@chu-grenoble.fr

Caroline SANDRE-BALLESTER, PhD

CONTACT

0438782851; csandreballester@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, proof-of-concept, multicenter, open-label study of feasibility and safety.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 17, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): June 30, 2031
• Last Updated: March 17, 2026

Record last verified: 2026-03