Depression and Facial Identity Recognition Abilities in Patients With Multiple Sclerosis (SepDep)

Depression and Reconnaissance of Emotions in Multiple Sclerosis Patients

Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases: depressive and bipolar disorders are twice as frequent as in general population.

Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early stages of the disease's evolution, in cases of lightly or moderately disabled patients, with a recent evolution, with a "minor" form of the disease, even in Clinically Isolated Syndromes (CIS). Emotional disturbances are essentially linked to mood disorders of depression-type.

Last ten years, emotional processing in multiple sclerosis cases was investigated in various trials, especially regarding the recognition of facial and emotional expressions. These studies reported data, supporting an impairment of the perception of emotion, particularly those with negative valence.

The objective of this study is to investigate the link between recognition of facial and emotional expressions and depression in multiple sclerosis cases.

Study Overview

• Status: Unknown
• Conditions: Depression; Multiple Sclerosis
• Intervention / Treatment: Other: Neuropsychological and emotional evaluation with monitoring

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• France
  • Nord Pas De Calais
    • Lille, Nord Pas De Calais, France, 59000
      • Recruiting
      • Hôpital Saint Vincent de Paul (GHICL)
      • Contact: Bruno Lenne; Phone Number: +3320875444; Email: lenne.bruno@ghicl.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Three groups will participate: Depressive MS patients, non depressive MS patients

and a control group

Description

Inclusion Criteria:

• Man or Woman between 18 and 65 years old
• Participant understanding and able to speak French
• Participant understanding the Participant Informed Sheet and who has signed the Informed Consent
• Participant with Health Insurance

MS Patients :

• Patient with relapsing remitting multiple sclerosis form
• Expanded Disability Status Scale (EDSS) < 4
• Patient without motor disorders, cerebellar or significant upper limb somatosensory or visual disturbances

Control Participants :

• Participant without global cognitive deterioration

Exclusion Criteria:

• Participant taking part of other biomedical studies involving drug tests
• Participant with other neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general affections, alcoholism, perception disorders, dysarthria, disorders preventing oral communication and reading, under prescription of psychotropic drugs
• Mental or visual incapacity to take part in the study
• Participant with antecedents of drug or alcohol abuse
• Allergy to the components of the gel used during the EEG
• Patients with MRI contraindications : Pacemaker or neurostimulator or Implantable Cardioverter Defibrillator (ICD), Cochlear Implants, ocular or cerebral ferromagnetic foreign body close to the nerve structures, metal prostheses,
• Uncooperative or agitated patients,
• Claustrophobic patients,
• Ventricular peritoneal shunts and neurosurgical valves,
• Braces
• MS patient without MRI in the last 4 months
• Adults under guardianship, under judicial protection, persons deprived of liberty,
• Pregnant or breast feeding women,
• MS patient with another MS form than Relapsing-Remitting,
• MS patient who encountered a relapse in the last 6 weeks,
• MS patient treated with corticoids in the last month.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Depressive MS patients; Neuropsychological and emotional evaluation with monitoring	Other: Neuropsychological and emotional evaluation with monitoring; Recognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests
Non depressive MS patients; Neuropsychological and emotional evaluation with monitoring	Other: Neuropsychological and emotional evaluation with monitoring; Recognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests
Control; Neuropsychological and emotional evaluation with monitoring	Other: Neuropsychological and emotional evaluation with monitoring; Recognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral)	first day of enrollement

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between facial identity recognition abilities and physiological index measured by electroencephalography	first day of enrollement
Correlation between facial identity recognition abilities and morphological index measured by magnetic resonance imaging	first day of enrollement
Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests	first day of enrollement

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Patrick Hautecoeur, MD, Groupment des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Depression; Depressive Disorder; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC-P0040