Impact of Neuropsychological Disorders in Multiple Sclerosis (SEVISEP)

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: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Three dimensional gait analysis with eyetracking

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amélie Lansiaux, MD, PhD; Phone Number: +33 3 20 22 52 69; Email: lansiaux.amelie@ghicl.net
• Study Contact Backup: Name: Mélanie Hamez; Phone Number: +33 3 20 22 57 31; Email: hamez.melanie@ghicl.net

Study Locations

• France
  • Lille, France
    • Recruiting
    • St Vincent hospital - neurological service
    • Contact: Brunno Lenne, PhD
  • Lomme, France
    • Recruiting
    • St Philibert hospital - Neurologial service
    • Contact: Arnaud Kwiatkowski, MD
  • Lomme, France
    • Recruiting
    • St Philibert hospital - Physical Medicine and Rehabilitation
    • Contact: Caroline MASSOT, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cadence of walking (in cycles.min-1)	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)	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)	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	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

Outcome Measure	Measure Description	Time Frame
Ocular fixation time (measured in ms)	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)	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	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	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	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

• Sponsor: Lille Catholic University
• Investigators: Study Director: Caroline Massot, MD, GHICL

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): January 21, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID 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