Status:
RECRUITING
Understanding Motor Function in Stroke Patients and Their Functional Brain Reorganization Using Ultra High-field MRI
Lead Sponsor:
Commissariat A L'energie Atomique
Conditions:
Stroke
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility 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.
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07339813
Start Date
December 10 2025
End Date
January 1 2029
Last Update
January 14 2026
Active Locations (1)
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1
NeuroSpin, CEA
Gif-sur-Yvette, Île-de-France Region, France, 91191