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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological tests
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Neurologie, Caen Hospital UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Neuropsychological tests

Arm Description

Outcomes

Primary Outcome Measures

anterograde episodic memory: 3 scores of emotional ESR
3 scores of emotional ESR
retrograde episodic memory: 9 scores TEMP emotional
9 scores TEMP emotional

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
August 7, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02518776
Brief Title
Influence of Emotional Disorders and Executive on the Components Retrograde and Anterograde Episodic Memory in MS
Acronym
ITEMS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuropsychological tests
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological tests
Intervention Description
Neuropsychological tests
Primary Outcome Measure Information:
Title
anterograde episodic memory: 3 scores of emotional ESR
Description
3 scores of emotional ESR
Time Frame
baseline
Title
retrograde episodic memory: 9 scores TEMP emotional
Description
9 scores TEMP emotional
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Neurologie, Caen Hospital University
City
Caen
State/Province
Basse-Normandie
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Defer, Professor
Phone
+33231064620
Email
defer.gi@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Nathalie Derache

12. IPD Sharing Statement

Learn more about this trial

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

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