Impact of Neuropsychological Disorders in Multiple Sclerosis
SEVISEP
1 other identifier
interventional
32
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started May 2021
Longer than P75 for not_applicable multiple-sclerosis
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
May 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2025
CompletedMarch 11, 2026
March 1, 2026
4.5 years
April 7, 2021
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Ocular fixation time (measured in ms)
60 days
Muscle contractions determined by the electromyogram (EMG) (mV)
60 days
Displacements (in mm) during walking
60 days
Acceleration (in mm.s-2) during walking
60 days
Joint angles
60 days
Study Arms (2)
patients with neuropsychological disorders
OTHERpatients without neuropsychological disorders
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St Vincent hospital - neurological service
Lille, France
St Philibert hospital - Neurologial service
Lomme, France
St Philibert hospital - Physical Medicine and Rehabilitation
Lomme, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Caroline Massot, MD
GHICL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2021
First Posted
April 8, 2021
Study Start
May 21, 2021
Primary Completion
November 7, 2025
Study Completion
December 7, 2025
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share