Influence of Emotional Disorders and Executive on the Components Retrograde and Anterograde Episodic Memory in MS (ITEMS)

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

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Neuropsychological tests

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Basse-Normandie
    • Caen, Basse-Normandie, France, 14033
      • Recruiting
      • Department of Neurologie, Caen Hospital University
      • Contact: Gilles Defer, Professor; Phone Number: +33231064620; Email: defer.gi@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Neuropsychological tests	Behavioral: Neuropsychological tests; Neuropsychological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Estimate): August 10, 2015
• Last Update Submitted That Met QC Criteria: August 7, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 09-016