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Impact of Neuropsychological Disorders in Multiple Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04837365
Acronym
SEVISEP
Enrollment
32
Registered
2021-04-08
Start date
2021-05-21
Completion date
2025-12-07
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief 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

Interventions

OTHERThree 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.

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Range of motion in the lower limbs in degrees60 daysThe 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)
Cadence of walking (in cycles.min-1)60 daysThe 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)
Step length (in m)60 daysThe 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)
Walking speed (in m.s-1)60 daysThe 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

MeasureTime frameDescription
Ocular fixation time (measured in ms)60 daysVisual 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.
Muscle contractions determined by the electromyogram (EMG) (mV)60 daysThe 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).
Displacements (in mm) during walking60 daysThe 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).
Acceleration (in mm.s-2) during walking60 daysThe 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).
Joint angles60 daysThe 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).

Countries

France

Contacts

STUDY_DIRECTORCaroline Massot, MD

GHICL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026