StrokeBCI4STROKE-ArmNCT07477613
Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke
A study testing BCI in people with Stroke, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2026to 8 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
- Presence of brain implants of metal clips and/or brain stimulators
- Severe dystonia/involuntary movements
- 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:
- No existing residual corticospinal tracts proven tractography and/or Motor Evoked Potential (MEP)
- Unability to control a BCI or unwillingness to follow a BCI rehabilitation program, assessed by MEG-BCI
- Unability to activate any residual motor regions during motor imagery assessed by EEG and functional MRI (fMRI)
- Shape of the skull in the implantation site not concordant with the WIMAGINE implant, assessed by anatomical MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHUGA
Grenoble, 38000
Olivier DETANTE, MD, PhD, 04 76 76 57 89, ODetante@chu-grenoble.fr
Caroline SANDRE-BALLESTER, PhD, 0438782851, csandreballester@chu-grenoble.fr
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- BCI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCIDevice
WIMAGINE
| Study group | Role | What they receive |
|---|---|---|
| REHABCI System | Experimental | WIMAGINE-based upper-limb neurorehabilitation therapy Receives: Device: BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after surgery
Secondary outcomes (1)
Efficacy of the task-oriented rehabilitation program using brain- controlled devices to perform daily life movements
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)
Measured: 7 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start8 Apr 2026
- Primary completion8 Apr 2029 (estimated)
- Study completion8 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, proof-of-concept, multicenter, open-label study of feasibility and safety.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- French Alternative Energies and Atomic Energy Commission (CEA), Grenoble
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477613
- Sponsor's protocol ID
- 2025-A01906-43 38RC25.0185
- Acronym
- BCI4STROKE-Arm
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31587955Mestais 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.
PubMed 25014960Eliseyev 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.
PubMed 25570185
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke
- ClinicalTrials.gov ID
- NCT07477613
- Acronym / sponsor ID
- BCI4STROKE-Arm / 2025-A01906-43 38RC25.0185
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- French Alternative Energies and Atomic Energy Commission (CEA), Grenoble
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 8 Apr 2029 (estimated)
- Study completion
- 8 Apr 2031 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, proof-of-concept, multicenter, open-label study of feasibility and safety.
| Arm | Type | Receives |
|---|---|---|
| REHABCI System | Experimental | Device: BCIWIMAGINE-based upper-limb neurorehabilitation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (33 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCIWIMAGINE | Device | REHABCI System |
Primary outcome
Safety of a wireless ECoG-based BCI using WIMAGINE® system in stroke patients
Time frame: 2 years after surgery
Serious adverse events associated with the chronic implantation of an extradural ECoG measuring implant
1 secondary outcome
Efficacy of the task-oriented rehabilitation program using brain- controlled devices to perform daily life movements
Time frame: 7 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 31587955Benabid 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.
- Background: PubMed 25014960Mestais 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.
- Background: PubMed 25570185Eliseyev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI in people with Stroke, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier DETANTE, MD, PhD (04 76 76 57 89, ODetante@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of a wireless ECoG-based BCI using WIMAGINE® system in stroke patients (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07477613, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.