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New treatment option for Stroke
Official title Implantable Brain-Computer Interface for Upper-Limb Recovery After Stroke
ClinicalTrials.gov ID: NCT07477613
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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
You likely can't join 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)
See the full eligibility criteria
- 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
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.