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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518776
Recruitment Status : Unknown
Verified August 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Neuropsychological tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : June 2010
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Neuropsychological tests Behavioral: Neuropsychological tests
Neuropsychological tests




Primary Outcome Measures :
  1. anterograde episodic memory: 3 scores of emotional ESR [ Time Frame: baseline ]
    3 scores of emotional ESR

  2. retrograde episodic memory: 9 scores TEMP emotional [ Time Frame: baseline ]
    9 scores TEMP emotional



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518776


Locations
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France
Department of Neurologie, Caen Hospital University Recruiting
Caen, Basse-Normandie, France, 14033
Contact: Gilles Defer, Professor    +33231064620    defer.gi@chu-caen.fr   
Principal Investigator: Nathalie Derache         
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02518776    
Other Study ID Numbers: 09-016
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases