Depression and Facial Identity Recognition Abilities in Patients With Multiple Sclerosis

Depression Clinical Trial

— SepDep  

Official title:

Depression and Reconnaissance of Emotions in Multiple Sclerosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02468765
• Other study ID #: RC-P0040
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2015
• Last updated: September 19, 2016
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: September 2016
• Source: Lille Catholic University
• Contact: Amélie Lansiaux, MD, PhD
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Saint Vincent de Paul (GHICL)	Lille	Nord Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral)		first day of enrollement	No
Secondary	Correlation between facial identity recognition abilities and physiological index measured by electroencephalography		first day of enrollement	No
Secondary	Correlation between facial identity recognition abilities and morphological index measured by magnetic resonance imaging		first day of enrollement	No
Secondary	Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests		first day of enrollement	Yes