MRI Hippocampal Microstructure and Episodic Memory in Early Multiple Sclerosis

NCT03692975 | Completed

• 1 other identifier: CHUBX 2017/30
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Clinically Isolated Syndrome; NODDI; Hippocampus; episodic memory function; dentate gyrus; MRI

Outcome Measures

Primary Outcomes (2)

• Index of orientation-dispersion (IOD)

  This parameter is measured in the dentate gyrus of hippocampus from NODDI imaging blind to the nature of the patient's group (CIS patients and controls).

  At baseline (day 0)

• Index of Neurite density (ND)

  This parameter is measured in the dentate gyrus of hippocampus from NODDI imaging blind to the nature of the patient's group (CIS patients and controls).

  At baseline (day 0)

Secondary Outcomes (12)

• Diffusion parameters : Index of orientation-dispersion

  At baseline (day 0)

• Diffusion parameters : Neurite density

  At baseline (day 0)

• Diffusion parameters : Fractional Anisotropy

  At baseline (day 0)

• Diffusion parameters : Mean diffusivity

  At baseline (day 0)

• Atrophy parameters

  At baseline (day 0)

Study Arms (2)

CIS patients

EXPERIMENTAL

Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially suggestive of multiple sclerosis (MS) whatever the mode of presentation

Other: Clinical assessment; Other: Neuropsychological evaluation; Other: Psychological evaluation; Device: MRI Evaluation

Control

ACTIVE COMPARATOR

50 Healthy controls

Other: Neuropsychological evaluation; Other: Psychological evaluation; Device: MRI Evaluation

Interventions

Clinical assessment OTHER

Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.

CIS patients

Neuropsychological evaluation OTHER

cognitive tests exploring episodic memories, information processing speed, attention/concentration and working memory.

CIS patients; Control

Psychological evaluation OTHER

included questionnaires for depression, anxiety, fatigue, cognitive complaint and reserve

CIS patients; Control

MRI Evaluation DEVICE

Diffusion including NODDI, 3DT1 with and without gadolinium, 3D-FLAIR before and after gadolinium infusion, 3D White Matter nulled-MPRAGE, 3D Double-Inversion recovery sequences-weighted imaging and Resting state functional MRI

CIS patients; Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - service de neurologie

Bordeaux, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Aurélie RUET, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Eric FRISON, MD, PhD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: October 2, 2018
• Study Start: February 12, 2019
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)