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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Commissariat A L'energie Atomique

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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