Clinical trial NCT03796247: Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event
Official title: Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event: Initial Phase of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: cognition
alexithymia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS patients admited in MS center of Lille after the first neurological inflammatory clinical event

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.

Detailed description: The aim to recruit 40 CIS patients with at least two subclinical lesions on brain MRI. Patients are tested only one month at least after steroids intake and after 6 weeks at least after any relapse. The control group include 40 right -handed participants; each of them are matched for age, gender, and education level with a CIS patient.

The parameters to be evaluated are:

The prevalence of alexithymia is assessed by The Toronto Alexithymia Scale TAS-20, a self-reported scale. The TAS-20 total score corresponds to global level of alexithymia, as the sum of these three subdomains: 1.Difficulties in Identifying Feelings (DIF); 2. Difficulties in Describing Feelings (DDF); 3. Externally Oriented Thinking (EOT).

Standard neurological examination is performed by a neurologist using the Kurtzke Expanded Disability Status Scale (EDSS ).

The standardized neuropsychological battery, named BCcogSEP, is administrated. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores were obtained and a score was considered impaired when it was inferior to 5th percentile range compared to the normal range. The number of impaired scores are considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th.

For psychobehavioral assessments, the investigators estimated (a) depression (according to the Beck Depression Inventory; BDI (30)) and anxiety (according to the State-Trait Anxiety Inventory (31)); (b) apathy (according to the Lille Apathy Rating Scale (32)); (c) empathy (according to Interpersonal Reactivity Index; IRI).

Eligibility criteria: Inclusion Criteria:

* right-handed patient
* at least 1 month after steroid intake
* without severe neurological impairment
* without psychiatric disorder

Exclusion Criteria:

* 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

Primary outcomes:
measure: Frequency of alexithymia in the CIS population
timeFrame: Baseline: one session
Secondary outcomes:
measure: relation between alexithymia and cognitive impairment in CIS patients and controls
timeFrame: Baseline: one session
measure: relation between alexithymia and thymic disorder in CIS and controls
timeFrame: Baseline: one session
measure: relation between alexithymia and thymic disorder in CIS and controls
timeFrame: Baseline: one session
measure: relation between alexithymia and thymic disorder in CIS and controls
timeFrame: Baseline: one session
measure: relation between alexithymia and thymic disorder in CIS and controls
timeFrame: Baseline: one session
measure: to evaluate the callosal functions and inter-hemispheric transfer in CIS and controls
timeFrame: Baseline: one session
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Hélène Zephir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: