Cognition and MRI Markers in MS Patients With Aubagio® Treatment

NCT03768648 | Completed

• 1 other identifier: CHUBX 2016/02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution. The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Immune System Diseases; Nervous System Diseases; Pathologic Processes; cognitive impairment; ecological assessment; brain MRI

Outcome Measures

Primary Outcomes (1)

• Change of composite z ecological score based on individual ecological scores.

  The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years).

  At baseline (day 0) and at 24 months from baseline

Secondary Outcomes (2)

• Change of composite z cognitive score based on individual neuropsychological scores

  At baseline (day 0) and at 24 months from baseline

• Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity

  At baseline (day 0) and at 24 months from baseline

Study Arms (2)

patient

EXPERIMENTAL

RRMS diagnosis according to McDonald criteria (Polman et al.,2005);

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

Control

ACTIVE COMPARATOR

40 Healthy controls (HC)

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

Interventions

Clinical assessment OTHER

EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded

patient

Ecological evaluation OTHER

Virtual reality task : Urban DailyCog© and Actual reality

Control; patient

Neuropsychological evaluation OTHER

cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function

Control; patient

Psychological evaluation OTHER

questionnaires for depression, anxiety and fatigue

Control; patient

MRI Evaluation DEVICE

morphological MRI and resting state functional MRI (fMRI)

Control; patient

Eligibility Criteria

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

You may qualify if:

• PATIENTS
• Male or female
• Age 18-60 years
• RRMS diagnosis according to McDonald criteria (Polman et al., 2005);
• Treated with Aubagio® (Indication for first line therapy)
• Native French speaking
• Being affiliated to health insurance
• HEALTHY CONTROLS
• Male or Female,
• Age 18-60 years
• Willing to participate and to sign informed consent.
• Being affiliated to health insurance

You may not qualify if:

• PATIENTS
• History of neurological disease and/or other neurological diseases,
• Psychiatric comorbidity including severe depression according to DSM-IV,
• 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
• Relapse since less than one month,
• Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
• Prior neuropsychological testing with the same tests less than 6 months
• 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, 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
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

CHU de Bordeaux - Service de neurologie

Bordeaux, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Immune System Diseases; Nervous System Diseases; Pathologic Processes; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Autoimmune Diseases; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Aurélie RUET, Prof

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

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: December 4, 2018
• First Posted: December 7, 2018
• Study Start: May 21, 2019
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

FR (1)