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OpenTrials
Completed

NCT Number: NCT04837365

Impact of Neuropsychological Disorders 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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent hospital - neurological service, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three dimensional gait analysis with eyetracking

Other

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: SEVISEP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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