Multiple SclerosisSEVISEPNCT04837365
Impact of Neuropsychological Disorders in Multiple Sclerosis
A study testing Three dimensional gait analysis with eyetracking in people with Multiple Sclerosis, run by Lille Catholic University at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Three dimensional gait analysis with eyetracking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 21 May 2021to 7 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
St Vincent hospital - neurological service
Lille
St Philibert hospital - Neurologial service
Lomme
St Philibert hospital - Physical Medicine and Rehabilitation
Lomme
About this study
Official title: 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
- Conditions
- Multiple Sclerosis
- Being tested
- Three dimensional gait analysis with eyetracking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensional gait analysis with eyetrackingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with neuropsychological disorders | Other | Not described Receives: Other: Three dimensional gait analysis with eyetracking |
| patients without neuropsychological disorders | Other | Not described Receives: Other: Three dimensional gait analysis with eyetracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 60 days
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 May 2021
- Primary completion7 Nov 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Massot, MD, Study director, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837365
- Sponsor's protocol ID
- RC-P00108
- Acronym
- SEVISEP
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04837365
- Acronym / sponsor ID
- SEVISEP / RC-P00108
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with neuropsychological disorders | Other | Other: Three dimensional gait analysis with eyetracking |
| patients without neuropsychological disorders | Other | Other: Three dimensional gait analysis with eyetracking |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three dimensional gait analysis with eyetrackingAn 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 with neuropsychological disorders, patients without neuropsychological disorders |
Primary outcome
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)
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)
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)
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)
5 secondary outcomes
Ocular fixation time (measured in ms)
Time frame: 60 days
Muscle contractions determined by the electromyogram (EMG) (mV)
Time frame: 60 days
Displacements (in mm) during walking
Time frame: 60 days
Acceleration (in mm.s-2) during walking
Time frame: 60 days
Joint angles
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Massot, MD study director
GHICL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three dimensional gait analysis with eyetracking in people with Multiple Sclerosis, run by Lille Catholic University at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence of walking (in cycles.min-1) (time frame: 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.