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NCT Number: NCT07339813

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuroSpin, CEA

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

Location status: Recruiting

Location contact

Myriam EDJLALI-GOUJON, MD, PhD

PRINCIPAL_INVESTIGATOR

Wissam ZAMOUN

CONTACT

[email protected]

+33 01.69.08.74.60

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional MRI (fMRI) Acquisition

Other

Participants undergo task-based and resting-state fMRI sessions, including motor imagery and motor execution tasks. Brain activity and clinical data are collected for analysis.

Primary outcomes

  1. Prediction accuracy of AI models for individual motor action intention

    Time frame: 1 day

    Validation of AI model predictions based on post-processing of functional MRI signals will be performed by comparing them with observed clinical performance during intentional motor tasks. These include assessment of movement intention of the hand and foot, intended movement direction, pathological side, and healthy side.

Study contacts

Contact information is provided by the study sponsor or research team.

Wissam ZAMOUN, ARC

CONTACT

[email protected]

+33 01.69.08.74.60

Sponsors and collaborators

Lead sponsor

Commissariat A L'energie Atomique

Other Gov

Registry information

Official study title

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

Acronym: MOTIF-STROKE

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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