Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event

NCT ID: NCT03796247

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-02
• Study Completion Date: 2016-05-31

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).

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

multiple sclerosis

No interventions assigned to this group

healthy control

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène Zephir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Roger Salengro, CHRU de Lille

Lille, , France

Countries

France

Other Identifiers

2011-A00016-35

Identifier Type: OTHER

Identifier Source: secondary_id

2010_39

Identifier Type: -

Identifier Source: org_study_id