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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство BCI
  WIMAGINE

Первичные конечные точки

• Safety of a wireless ECoG-based BCI using WIMAGINE® system in stroke patients [Срок оценки: 2 years after surgery]

Вторичные конечные точки (1)

• Efficacy of the task-oriented rehabilitation program using brain- controlled devices to perform daily life movements [Срок оценки: 7 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Франция · 1 центр

• CHUGA — Grenoble

Публикации

• 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-concep PMID 31587955
• 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
• 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; PMID 25570185

Идентификаторы

NCT: NCT07477613 · 2025-A01906-43 38RC25.0185

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗