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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468765
Recruitment Status : Unknown
Verified September 2016 by Lille Catholic University.
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Depression Other: Neuropsychological and emotional evaluation with monitoring

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Depression and Reconnaissance of Emotions in Multiple Sclerosis Patients
Study Start Date : May 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral) [ Time Frame: first day of enrollement ]

Secondary Outcome Measures :
  1. Correlation between facial identity recognition abilities and physiological index measured by electroencephalography [ Time Frame: first day of enrollement ]
  2. Correlation between facial identity recognition abilities and morphological index measured by magnetic resonance imaging [ Time Frame: first day of enrollement ]
  3. Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests [ Time Frame: first day of enrollement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

and a control group

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468765


Contacts
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Contact: Amélie Lansiaux, MD, PhD lansiaux.amelie@ghicl.net
Contact: Ibrahima Diop, Med Monitor diop.ibrahima@ghicl.net

Locations
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France
Hôpital Saint Vincent de Paul (GHICL) Recruiting
Lille, Nord Pas De Calais, France, 59000
Contact: Bruno Lenne    +3320875444    lenne.bruno@ghicl.net   
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Patrick Hautecoeur, MD Groupment des Hôpitaux de l'Institut Catholique de Lille
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02468765    
Other Study ID Numbers: RC-P0040
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases