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

January 5, 2026 updated by: Myriam Edjlali-Goujon, Commissariat A L'energie Atomique

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Île-de-France Region
      • Gif-sur-Yvette, Île-de-France Region, France, 91191
        • Recruiting
        • NeuroSpin, CEA
        • Contact:
        • Principal Investigator:
          • Myriam EDJLALI-GOUJON, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Chronic-Phase Ischemic Stroke Patients and Healthy Volunteer Optimization
Participants undergo task-based and resting-state fMRI sessions. Imaging and clinical data are collected and analyzed using artificial intelligence models.
Other: Functional MRI (fMRI) Acquisition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Commissariat A L'energie Atomique

Investigators

  • Principal Investigator: Myriam Edjlali-Goujon, MD, PhD, Commissariat A L'energie Atomique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEA 100 077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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