TerminatedNot Applicable

MRI Hippocampal Microstructure and Episodic Memory in Early Multiple Sclerosis

Stopped: target number of patient not reached

France84 participantsStarted 2019-02-12

Plain-language summary

Clinically isolated syndrome (CIS) can evolve into multiple sclerosis. In CIS patients, episodic memory is frequently impaired. Memory disorders could be preceded by microstructural abnormalities without visible atrophy in hippocampus. A recent MRI imaging of diffusion called NODDI (Neurite Orientation Dispersion and Density Imaging) can measure specifically microstructural abnormalities and map the axons in the white matter (WM) and dendrites in the grey matter (GM). The aim of this study is to evaluate microstructural abnormalities in the dentate gyrus of the hippocampus in CIS patients compared to controls.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- PATIENTS: * Men and Women, * Age 18-60 years, * Native French language, * Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation, * Between 60 and 180 days from the onset, * At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of least 3 mm, at least one of which being cerebral, ovoid, or periventricular, * Willing to participate and to sign informed consent. * \- HEALTHY CONTROLS * Men and Women, * Age 18-60years, * Native French language, * Willing to participate and to sign informed consent. Exclusion Criteria: * \- PATIENTS: * Prior documented neurological episode suggestive of MS, * History of neurological disease and/or other neurological diseases, * Psychiatric diseases, * Known chronic systemic diseases as judged by the investigator, * Alcohol or other addiction to toxic, * Disabling visual or motor problems preventing participation to neuropsychological assessments, * Acquisition disorders : Dyslexia, Dysphasia, Dyscalculia and dyspraxia, * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 30 days, * Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Index of orientation-dispersion (IOD)

Timeframe: At baseline (day 0)

Index of Neurite density (ND)

Timeframe: At baseline (day 0)

Trial details

NCT IDNCT03692975

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-24

View on ClinicalTrials.gov More Multiple Sclerosis trials