Impact of Neuropsychological Disorders in Multiple Sclerosis (SEVISEP)

March 10, 2026 updated by: Lille Catholic University

Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis

The study involves MS patients with and without neuropsychological disorders.

The patient will benefit from:

  • A routine neuropsychological assessment, including a cognitive and emotional assessment
  • A clinical examination
  • A three-dimensional analysis of movement

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • St Vincent hospital - neurological service
      • Lomme, France
        • St Philibert hospital - Neurologial service
      • Lomme, France
        • St Philibert hospital - Physical Medicine and Rehabilitation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Understanding and able to speak French
  • Carriers of MS with relapsing remitting form (RRMS-RR) with an EDSS <4
  • No significant motor, cerebellar or somesthesia disorders of the upper limbs or visual disturbances (side to a visual EDSS <2)
  • Absence of corticosteroid intake in the last four weeks
  • Benefiting from health insurance coverage
  • Not showing any flare-ups or worsening of the disease in the last 6 weeks
  • No botulinum toxin injection for more than 4 months

Exclusion Criteria:

  • People with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general ailments, perceptual or dysarthric disorders preventing verbal communication or reading,
  • Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
  • Refusal to participate after clear and fair information about the study.
  • Adults under tutorship, curatorship or safeguard of justice
  • With orthopedic treatment influencing walking
  • Pregnant woman

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: patients with neuropsychological disorders
Other: Three dimensional gait analysis with eyetracking
An emotional impregnation and eye pursuit assessment are specific to the study. Emotional impregnation involves making the patient look at images from the International Affective Picture System (IAPS) on a screen before initiating walking. The equipment will be identical to that of the patient during walking tasks. Eye movement analysis is performed using a pair of eyetracking glasses.
Other: patients without neuropsychological disorders
Other: Three dimensional gait analysis with eyetracking
An emotional impregnation and eye pursuit assessment are specific to the study. Emotional impregnation involves making the patient look at images from the International Affective Picture System (IAPS) on a screen before initiating walking. The equipment will be identical to that of the patient during walking tasks. Eye movement analysis is performed using a pair of eyetracking glasses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cadence of walking (in cycles.min-1)
Time Frame: 60 days
The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)
60 days
Step length (in m)
Time Frame: 60 days
The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)
60 days
Walking speed (in m.s-1)
Time Frame: 60 days
The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)
60 days
Range of motion in the lower limbs in degrees
Time Frame: 60 days
The kinematics of the initiation of walking and walking will be appreciated thanks to the variables calculated at the level of the joints of the lower limbs as well as the spatio-temporal parameters without and with management of obstacles (taking a step, balloon)
60 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ocular fixation time (measured in ms)
Time Frame: 60 days
Visual exploration will be appreciated by the Ocular fixation time (measured in ms), when initiating walking, walking at spontaneous speed and when passing obstacles with or without a cognitive task. Visual exploration will also be measured after emotional priming when initiating walking and walking. This emotional priming will consist of the transfer of images from the International Affective Picture System (IAPS). This measurement will be carried out using eyetracking glasses worn by patients.
60 days
Muscle contractions determined by the electromyogram (EMG) (mV)
Time Frame: 60 days
The motor patterns (organizations of muscle contractions determined by measuring the EMG of muscles representative of walking) (mV) of the femoral, semi-tendinous, anterior tibial and soleus rectus muscles will be measured using surface EMG , for the two locomotor tasks (walking and initiation to walking), during walking at spontaneous speed (without double task, without crossing an obstacle).
60 days
Displacements (in mm) during walking
Time Frame: 60 days
The displacements (in mm) of the center of the body mass and of the center of pressure on the anteroposterior and mediolateral axes will be derived from the force platforms during the initiation of walking in different conditions (without and with emotional priming).
60 days
Acceleration (in mm.s-2) during walking
Time Frame: 60 days
The acceleration (in mm.s-2) of the center of the body mass and of the center of pressure on the anteroposterior and mediolateral axes will be derived from the force platforms during the initiation of walking in different conditions (without and with emotional priming).
60 days
Joint angles
Time Frame: 60 days
The articular moments and torques (Nm) at the joints of the lower limbs during the initiation to walking will be calculated from kinematic data from the motion analysis laboratory and dynamics of force platforms (without and with priming emotional).
60 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lille Catholic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Caroline Massot, MD, GHICL

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC-P00108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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