MRI Hippocampal Microstructure and Episodic Memory in Early Multiple S

Hippocampal Microstructure Assessed by a New MRI Sequence and Episodic Memory at the Early Stage of Multiple Sclerosis: Comparison Between Patients After a Clinically Isolated Syndrome (CIS) and Controls

Stopped earlyNot a drug-phase studyEarly (CIS/RIS)NCT03692975

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: target number of patient not reached

What was tested

Treatment tested

  • Clinical assessment

Given to everyone in the trial

  • Neuropsychological evaluation
  • Psychological evaluation
  • MRI Evaluation

What it measured

Main measures

  • Index of orientation-dispersion (IOD)

    At baseline (day 0)

  • Index of Neurite density (ND)

    At baseline (day 0)

Other measures (12)

  • Diffusion parameters : Index of orientation-dispersion

    At baseline (day 0)

    MRI lesions

  • Diffusion parameters : Neurite density

    At baseline (day 0)

    MRI lesions

  • Diffusion parameters : Fractional Anisotropy

    At baseline (day 0)

    MRI lesions

  • Diffusion parameters : Mean diffusivity

    At baseline (day 0)

    MRI lesions

  • Atrophy parameters

    At baseline (day 0)

    MRI lesionsBrain volume loss

  • Lesion volume

    At baseline (day 0)

    MRI lesionsBrain volume loss

  • Inflammatory activity

    At baseline (day 0)

    MRI lesionsBrain volume loss

  • Connectivity

    At baseline (day 0)

    MRI lesionsNerve conduction tests

  • Verbal episodic memory test

    At baseline (day 0)

    Thinking and memory

  • Visual episodic memory score

    At baseline (day 0)

    Thinking and memory

Who could take part

Early (CIS/RIS) · 18 to 60

Show the full criteria

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, claustrophobia), * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily, * Illiteracy, is unable to count or to read, * Pregnant or breastfeeding women, * Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent). * - HEALTHY CONTROLS * History of neurological disease and/or neurological diseases, * Psychiatric diseases, * Known chronic systemic diseases as judged by the investigator, * Alcohol or other addiction to toxic, * Acquisition disorders: Dyslexia, Dysphasia, Dyscalculia and dyspraxia, * Known cognitive impairment or Prior neuropsychological testing with the same tests less than one year, * Hypnotic or anxiolytic or antidepressive treatment, * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily, * Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI, * Illiteracy, unable to count or to read, * Pregnant or breastfeeding women, * Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2019

    2. Main results due

      Feb 2023

    3. Finished

      Feb 2023

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