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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07339813
Acronym
MOTIF-STROKE
Enrollment
110
Registered
2026-01-14
Start date
2025-12-10
Completion date
2029-01-31
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

motor disability, functionnal MRI, High-field MRI, disconnection atlas, diffusion-weighted MRI, machine learning algorithms

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 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.

Interventions

OTHERFunctional 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.

Sponsors

Commissariat A L'energie Atomique
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

RIPH 2

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prediction accuracy of AI models for individual motor action intention1 dayValidation 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.

Countries

France

Contacts

Primary ContactWissam ZAMOUN, ARC
wissam.zamoum@cea.fr+33 01.69.08.74.60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026