Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event
ALEXCIS
2 other identifiers
observational
57
1 country
1
Brief Summary
Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances. In this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedJanuary 8, 2019
January 1, 2019
5 years
January 3, 2019
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of alexithymia in the CIS population
alexithymia is defined according to TAS-20 (Toronto Alexithymia Scale) The Toronto Alexithymia Scale is a measure of deficiency in understanding, processing, or describing emotions. The current version has twenty statements rated on a five-point Likert scale. ( range : Strongly disagree/Disagree/ Neither agree nor disagree/ Agree/ Strongly agree)
Baseline: one session
Secondary Outcomes (6)
relation between alexithymia and cognitive impairment in CIS patients and controls
Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Baseline: one session
- +1 more secondary outcomes
Study Arms (2)
multiple sclerosis
healthy control
Eligibility Criteria
MS patients admited in MS center of Lille after the first neurological inflammatory clinical event
You may qualify if:
- right-handed patient
- at least 1 month after steroid intake
- without severe neurological impairment
- without psychiatric disorder
You may not qualify if:
- patients with steroids in the last month
- patients with psychotropic drugs started in the last month
- patients with immunotherapies
- patients having contra indications for MRI
- pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Roger Salengro, CHRU de Lille
Lille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène Zephir, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 8, 2019
Study Start
May 2, 2011
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
January 8, 2019
Record last verified: 2019-01