Impact of Neuropsychological Disorders in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— SEVISEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837365
• Other study ID #: RC-P00108
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: Lille Catholic University
• Contact: Amélie Lansiaux, MD, PhD
• Phone: +33 3 20 22 52 69
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: January 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	St Vincent hospital - neurological service	Lille
France	St Philibert hospital - Neurologial service	Lomme
France	St Philibert hospital - Physical Medicine and Rehabilitation	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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