NCT02518776

Brief Summary

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible for physical disability but can also cause cognitive disturbances annoying social and professional life of patients with the disease. Various studies have shown that there was a breach of episodic memory, working memory, attention and executive functions regardless of the form of disease, disability or duration of disease progression. The main objective of this study is to investigate the influence of emotional components and executive processes on the components retrograde and anterograde episodic memory (thanks to an original paradigm based on the emotional valence of the memory) in MS patients

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

6.1 years

First QC Date

August 6, 2015

Last Update Submit

August 7, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • anterograde episodic memory: 3 scores of emotional ESR

    3 scores of emotional ESR

    baseline

  • retrograde episodic memory: 9 scores TEMP emotional

    9 scores TEMP emotional

    baseline

Study Arms (1)

Neuropsychological tests

OTHER
Behavioral: Neuropsychological tests

Interventions

Neuropsychological tests

Neuropsychological tests

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women 30-60 years of age
  • Definite MS (McDonald criteria revised in 2005)
  • EDSS \<6
  • Sick Shapes: Relapsing multiple sclerosis, Primary progressive multiple sclerosis
  • All durations evolution
  • French Mother tongue
  • Signature of informed consent

You may not qualify if:

  • Other neurological conditions, previous psychiatric or developmental diagnosis of MS
  • Head injury sequelae
  • Chronic alcohol or drugs Taking
  • EDSS greater than or equal to 6
  • Secondary Progressive Form
  • Push and / or treatment with corticosteroids within one month
  • Treatments Amantadine, Modafinil introduced for less than 3 months
  • Patient Trust
  • Cognitive Assessment of less than one year (including in particular all or part of the balance sheet proposed in this project)
  • Any visual motor deficit or incompatible with the award of cognitive tests
  • For women, pregnancy, breastfeeding and / or lack of contraception (a pregnancy test will be done before the PET scan)
  • Patient with indications against MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurologie, Caen Hospital University

Caen, Basse-Normandie, 14033, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 10, 2015

Study Start

June 1, 2010

Primary Completion

July 1, 2016

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations