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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NeuroSpin, CEA

Gif-sur-Yvette, Île-de-France Region, France, 91191

Understanding Motor Function in Stroke Patients and Their Functional Brain Reorganization Using Ultra High-field MRI | DecenTrialz