Depression and Facial Identity Recognition Abilities in Patients With Multiple Sclerosis

NCT02468765 | Completed

• 1 other identifier: RC-P0040
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Depression

Outcome Measures

Primary Outcomes (1)

• Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral)

  Rates of correct responses to the different questions of the EFEs recognition test (categorization of emotional expression (anger, joy, or neutral), assessment of the intensity of the emotion, and the degree of certainty of the responses given), compared between the three groups of participants.

  first day of enrollement

Secondary Outcomes (3)

• 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

Study Arms (3)

Depressive MS patients

Neuropsychological and emotional evaluation with monitoring

Other: Neuropsychological and emotional evaluation with monitoring

Non depressive MS patients

Neuropsychological and emotional evaluation with monitoring

Other: Neuropsychological and emotional evaluation with monitoring

Control

Neuropsychological and emotional evaluation with monitoring

Other: Neuropsychological and emotional evaluation with monitoring

Interventions

Neuropsychological and emotional evaluation with monitoring OTHER

Recognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests

Control; Depressive MS patients; Non depressive MS patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Three groups will participate: Depressive MS patients, non depressive MS patients and a control group

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Hôpital Saint Vincent de Paul (GHICL)

Lille, Hauts-de-France, 59000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Patrick Hautecoeur, MD

  Groupment des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: April 24, 2015
• Primary Completion: May 30, 2016
• Study Completion: May 30, 2016
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)