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

Multiple Sclerosis Clinical Trial

— ITEMS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02518776
• Other study ID #: 09-016
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 7, 2015
• Start date: June 2010

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Behavioral:
• Neuropsychological tests
Neuropsychological tests

Locations

Country	Name	City	State
France	Department of Neurologie, Caen Hospital University	Caen	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anterograde episodic memory: 3 scores of emotional ESR	3 scores of emotional ESR	baseline	No
Primary	retrograde episodic memory: 9 scores TEMP emotional	9 scores TEMP emotional	baseline	No