Assessment of the Frequency of Functional Neurological Disorders in Multiple Sclerosis and Analysis of Clinical and Psychological Determinants (FTNF-SEP)

October 2, 2026 updated by: University Hospital, Strasbourg, France

Assessment of the Frequency of Functional Neurological Disorders in Multiple Sclerosis and Analysis of Clinical and Psychological Determinants: A Multicenter Cross-Sectional Study

Multiple sclerosis (MS) and functional neurological disorders (FND) share clinical features, which may result in FND being overlooked in patients with MS. They also share common comorbidities, including depression and alexithymia.

As their management differs, assessing the frequency and determinants of FND in patients with MS is important to improve diagnosis and ensure appropriate management.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

As their management differs, assessing the frequency and determinants of FND in patients with MS is important to improve diagnosis and ensure appropriate management.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: BEN HADJ HAMED Monia
Phone Number: 003388116711
Email: monia.ben-hadj-hamed@chru-strasbourg.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

During a routine medical visit, eligible patients will be informed about the study and invited to participate.

The two participating centers, located in Strasbourg and Nancy, each have an active cohort allowing the required number of participants to be recruited within one year.

Description

Inclusion Criteria:

Adult patient (≥ 18 years of age)
Diagnosis of multiple sclerosis (MS) according to the 2024 McDonald criteria
Stable brain MRI performed within the previous 12 months
No relapse between the MRI and study enrollment
Ability to understand French
Affiliated with the French national health insurance system
Willing to participate in the study

Exclusion Criteria:

Patient unwilling to participate in the study
Known severe psychotic disorder
Patient under judicial protection (sauvegarde de justice)
Patient under guardianship or curatorship (tutelle or curatelle)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: CASE_ONLY
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the frequency of TNF in patients with multiple sclerosis Time Frame: Baseline	Assessment of the frequency of TNF in patients with multiple sclerosis	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

Principal Investigator: BIGAUT Kevin, Doctor, Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 2, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 24, 2026

First Submitted That Met QC Criteria

September 24, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

October 7, 2026

Last Update Submitted That Met QC Criteria