Clinical trial NCT02468765: Depression and Facial Identity Recognition Abilities in Patients With Multiple Sclerosis
Official title: Depression and Reconnaissance of Emotions in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Depression
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups will participate: Depressive MS patients, non depressive MS patients

and a control group

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral)
timeFrame: first day of enrollement
Secondary outcomes:
measure: Correlation between facial identity recognition abilities and physiological index measured by electroencephalography
timeFrame: first day of enrollement
measure: Correlation between facial identity recognition abilities and morphological index measured by magnetic resonance imaging
timeFrame: first day of enrollement
measure: Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests
timeFrame: first day of enrollement
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul (GHICL)
state: Nord Pas De Calais
Study officials:
affiliation: Groupment des Hôpitaux de l'Institut Catholique de Lille
name: Patrick Hautecoeur, MD
role: PRINCIPAL_INVESTIGATOR
References: