StrokeMOTIF-STROKENCT07339813
Understanding Motor Function in Stroke Patients and Their Functional Brain Reorganization Using Ultra High-field MRI
A study testing Functional MRI (fMRI) Acquisition in people with Stroke, run by Commissariat A L'energie Atomique at 1 site in France.
Trial 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 anatomo-functional disconnection atlas in a cohort of 100 stroke patients, using cutting-edge 3T and 7T MRI. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Functional MRI (fMRI) Acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
NeuroSpin, CEA
Gif-sur-Yvette, Île-de-France Region, 91191
Wissam ZAMOUN, +33 01.69.08.74.60, wissam.zamoum@cea.fr
Myriam EDJLALI-GOUJON, MD, PhD
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Functional MRI (fMRI) Acquisition
- Keywords
- motor disability, functionnal MRI, High-field MRI, disconnection atlas, diffusion-weighted MRI, machine learning algorithms
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI (fMRI) AcquisitionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic-Phase Ischemic Stroke Patients and Healthy Volunteer Optimization | Other | Participants undergo task-based and resting-state fMRI sessions. Imaging and clinical data are collected and analyzed using artificial intelligence models. Receives: Other: Functional MRI (fMRI) Acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction accuracy of AI models for individual motor action intention
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start10 Dec 2025
- Primary completionNov 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- RIPH 2
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Commissariat A L'energie Atomique
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Myriam Edjlali-Goujon, Commissariat A L'energie Atomique
- Investigators
- Myriam Edjlali-Goujon, MD, PhD, Principal investigator, Commissariat A L'energie Atomique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339813
- Sponsor's protocol ID
- CEA 100 077
- Acronym
- MOTIF-STROKE
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Motor Function in Stroke Patients and Their Functional Brain Reorganization Using Ultra High-field MRI (MOTF-STROKE)
- ClinicalTrials.gov ID
- NCT07339813
- Acronym / sponsor ID
- MOTIF-STROKE / CEA 100 077
- Conditions
- Stroke
- Keywords
- motor disability, functionnal MRI, High-field MRI, disconnection atlas, diffusion-weighted MRI, machine learning algorithms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Commissariat A L'energie AtomiqueOther government
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RIPH 2
| Arm | Type | Receives |
|---|---|---|
| Chronic-Phase Ischemic Stroke Patients and Healthy Volunteer Optimization | Other | Other: Functional MRI (fMRI) AcquisitionParticipants undergo task-based and resting-state fMRI sessions. Imaging and clinical data are collected and analyzed using artificial intelligence models. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRI (fMRI) AcquisitionParticipants undergo task-based and resting-state fMRI sessions, including motor imagery and motor execution tasks. Brain activity and clinical data are collected for analysis. | Other | Chronic-Phase Ischemic Stroke Patients and Healthy Volunteer Optimization |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Myriam Edjlali-Goujon, MD, PhD principal investigator
Commissariat A L'energie Atomique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional MRI (fMRI) Acquisition in people with Stroke, run by Commissariat A L'energie Atomique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wissam ZAMOUN, ARC (+33 01.69.08.74.60, wissam.zamoum@cea.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction accuracy of AI models for individual motor action intention (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.