Mapping how the brain reorganizes arm movement after stroke using ultra‑high‑field MRI
Understanding Motor Function in Stroke Patients and Their Functional Brain Reorganization Using Ultra High-field MRI (MOTF-STROKE)
This project will use 3T and 7T MRI scans to see if detailed brain connectivity maps can explain and help predict upper‑limb motor problems in people who had a first ischemic stroke more than six months ago.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Commissariat A L'energie Atomique Government |
| Locations | 1 site (Gif-sur-Yvette, Île-de-France Region) |
| Trial ID | NCT07339813 on ClinicalTrials.gov |
What this trial studies
Embedded in the BrainSync program, the MOTIF‑STROKE project will acquire high‑resolution structural (T1), task‑related functional, and diffusion‑weighted MRI data in a cohort of about 100 chronic stroke patients using 3T and 7T scanners beginning in Fall 2025. Data will be used to perform morphometry and both structural and functional connectivity analyses to build an anatomo‑functional disconnection atlas tied to measurable motor deficits. Task‑related fMRI paradigms and digital tools will link connectivity patterns to motor performance, while machine learning and functional hyper‑alignment approaches will test which input features best predict deficits. The ultimate goal is to use the atlas to optimize placement and selection of WIMAGINE neuroprostheses for later BCI implantation trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–70 with a single MRI‑confirmed ischemic stroke more than six months earlier, persistent upper‑limb motor deficit, preserved cognition (MMSE ≥27), and the ability to perform task‑based fMRI and give informed consent.
Not a fit: Patients with recurrent strokes, severe aphasia or comprehension deficits, major visual or hearing impairments, significant cognitive impairment, limited life expectancy, or standard MRI contraindications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the atlas could help tailor neuroprosthetic placement and rehabilitation strategies to each patient’s brain connectivity, improving upper‑limb function.
How similar studies have performed: Prior work has linked structural and functional connectivity to motor outcomes after stroke, but creating a high‑resolution 7T anatomo‑functional disconnection atlas and applying hyper‑alignment plus machine learning for neuroprosthesis planning is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gif-sur-Yvette, Île-de-France Region
- NeuroSpin, CEA — Gif-sur-Yvette, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Myriam Edjlali-Goujon, MD, PhD — Commissariat A L'energie Atomique
- Study coordinator: Wissam ZAMOUN, ARC
- Email: wissam.zamoum@cea.fr
- Phone: +33 01.69.08.74.60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.