Understanding Motor Function in Stroke Patients and Their Functional Brain Reorganization Using Ultra High-field MRI (MOTIF-STROKE)

Commissariat A L'energie Atomique

Status: Enrolling

Conditions: Stroke

Treatments: Other: Functional MRI (fMRI) Acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT07339813

CEA 100 077

Details and patient eligibility

About

The MOTIF-STROKE study is embedded within the BrainSync project, aiming to develop innovative strategies for motor rehabilitation of the upper limb. The primary goal is to construct a high-resolution anatomo-functional disconnection atlas in a cohort of 100 stroke patients, using cutting-edge 3T and 7T MRI. Data acquisition, commencing in Fall 2025, will combine morphological (T1-weighted), functional and diffusion-weighted MRI scans to perform morphometry, functional and structural connectivity analyses with biomarkers of motor deficits. This atlas seeks to correlate connectivity with motor tasks, using dedicated task-related fMRI paradigms and digital consultation tools. The project utilizes machine learning algorithms and functional hyper-alignment to analyze fMRI data, focusing on input features and their impact on prediction accuracy. The ultimate objective is to optimize implantation of WIMAGINE neuroprostheses for the subsequent BCI4STROKE clinical trial. Expected results include identifying clinical subgroups responsive to motor intention decoding, characterizing phenotypes of functional reorganization, and making the 3D brain atlas accessible to the neuroscience community.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients

• 1-MRI-confirmed diagnosis of a first ischemic stroke occurring more than 6 months prior to inclusion.
• 2-Persistent upper-limb motor deficit resulting from the stroke.
• 3-Absence of significant cognitive impairment: MMSE score ≥ 27 assessed as part of clinical care.
• 4-Age between 18 and 70 years.
• 5-Validation by the inclusion validation committee.
• 6-Signed informed consent after clear and fair information about the study.

Healthy volunteers:

• 1-Age between 18 and 70 years.
• 2-No history of neurological or psychiatric disease.
• 3-Signed informed consent after clear and fair information about the study.

Exclusion criteria

Patients:

• 1-Recurrent stroke.
• 2-Severe aphasia or severe speech disorders preventing adequate interaction for the protocol.
• 3-Severe auditory or visual impairment.
• 4-Disorders of comprehension, attention, or neglect affecting understanding of study motor tasks.
• 5-Associated conditions with an estimated life expectancy of less than 2 years.
• 6-History of brain surgery, craniectomy, or cranioplasty.
• 7-Other causes of motor disability.
• 8-Alcohol consumption the day before or on the day of the examination, or use of illicit psychotropic substances within 48 hours prior to MRI.
• 9-Absolute contraindications to MRI, including pregnancy; intracorporeal metallic foreign bodies; pacemakers; non-MRI-compatible neurostimulators; cochlear implants; implanted medical devices (electronic or non-electronic) implanted for less than 6 weeks; metallic heart valves; stents, coils, carotid or neurosurgical clips; implantable ports; infusion pumps; non-removable piercings; tattoos or permanent makeup larger than 5 cm on the head, neck, trunk, or upper limbs; transdermal devices with metallic components; intrauterine devices (except Mirena); dental appliances larger than 4 cm; or health conditions incompatible with MRI comfort and safety (e.g., acute respiratory or cardiac failure, inability to remain supine, bedridden state, claustrophobia).
• 10-Individuals not covered by a social security system.
• 11-Individuals under enhanced protection, including pregnant or breastfeeding women, persons deprived of liberty, legally protected adults, or patients in emergency situations.
• 12-Pregnant or breastfeeding women, or women of childbearing potential refusing a pregnancy test.

Healthy volunteer:

• 1-Absolute contraindications to MRI as listed above.
• 2-Individuals not covered by a social security system.
• 3-Individuals under enhanced protection, including pregnant or breastfeeding women, persons deprived of liberty, legally protected adults, or patients in emergency situations.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Chronic-Phase Ischemic Stroke Patients and Healthy Volunteer Optimization

Other group

Description:

Participants undergo task-based and resting-state fMRI sessions. Imaging and clinical data are collected and analyzed using artificial intelligence models.

Treatment:

Other: Functional MRI (fMRI) Acquisition