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

August 7, 2015 updated by: University Hospital, Caen

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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
    • Basse-Normandie
      • Caen, Basse-Normandie, France, 14033
        • Recruiting
        • Department of Neurologie, Caen Hospital University
        • Contact:

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

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

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

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
Time Frame: baseline
3 scores of emotional ESR
baseline
retrograde episodic memory: 9 scores TEMP emotional
Time Frame: baseline
9 scores TEMP emotional
baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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

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

Other Study ID Numbers

  • 09-016

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.

Subscribe