Cognition and MRI Markers in MS Patients With Aubagio® Treatment (AUBACOG)

February 2, 2022 updated by: University Hospital, Bordeaux

Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting

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®.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux - Service de neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
  • Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)

HEALTHY CONTROLS

  • Male or Female,
  • Age 18-60 years
  • Willing to participate and to sign informed consent.
  • Being affiliated to health insurance
  • Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)

Exclusion Criteria:

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

  • History of neurological disease and/or neurological diseases
  • Psychiatric comorbidity including severe depression according to DSM-IV;
  • Alcohol or other toxic addiction;
  • Known cognitive complaint or neuropsychological affection
  • Hypnotic or anxiolytic or antidepressive treatment,
  • Prior neuropsychological testing with the same tests less than 6 months
  • Acquisition disorders: Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
  • 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, is unable to count or to read
  • Pregnant or breastfeeding women
  • Person 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient
RRMS diagnosis according to McDonald criteria (Polman et al.,2005);
Other: Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Other: Psychological evaluation
questionnaires for depression, anxiety and fatigue
Device: MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)
Other: Clinical assessment
EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded
Other: Ecological evaluation
Virtual reality task : Urban DailyCog© and Actual reality
Active Comparator: Control
40 Healthy controls (HC)
Other: Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Other: Psychological evaluation
questionnaires for depression, anxiety and fatigue
Device: MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)
Other: Ecological evaluation
Virtual reality task : Urban DailyCog© and Actual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of composite z ecological score based on individual ecological scores.
Time Frame: At baseline (day 0) and at 24 months from baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of composite z cognitive score based on individual neuropsychological scores
Time Frame: At baseline (day 0) and at 24 months from baseline
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. 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. Individual neuropsychological scores included in composite z cognitive score : the Alertness subtest, the divided attention subtest and the visual-scanning subtest from the TAP, The Symbol-digit-modalities-test, the Paced-Auditory-Serial-Addition-Test 3s, reversed span, the Stroop test, the Verbal fluency, Trail Making test, the California Verbal memory learning test and the Brief visual memory test -revised.
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
Time Frame: At baseline (day 0) and at 24 months from baseline
The composite z cognitive score and the composite ecological score are the average of z individual cognitive and ecological scores. The score from each cognitive and ecological test is transformed into z-scores. 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.
At baseline (day 0) and at 24 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Aurélie RUET, Prof, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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