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Impact of Neuropsychological Disorders in Multiple Sclerosis (SEVISEP)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Three dimensional gait analysis with eyetracking
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Vincent hospital - neurological serviceRecruiting
  • St Philibert hospital - Neurologial serviceRecruiting
  • St Philibert hospital - Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

patients with neuropsychological disorders

patients without neuropsychological disorders

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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.
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).
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).
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).
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).

Full Information

First Posted
April 7, 2021
Last Updated
June 21, 2023
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04837365
Brief Title
Impact of Neuropsychological Disorders in Multiple Sclerosis
Acronym
SEVISEP
Official Title
Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
January 21, 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with neuropsychological disorders
Arm Type
Other
Arm Title
patients without neuropsychological disorders
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Three dimensional gait analysis with eyetracking
Intervention Description
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 Outcome Measure Information:
Title
Cadence of walking (in cycles.min-1)
Description
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)
Time Frame
60 days
Title
Step length (in m)
Description
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)
Time Frame
60 days
Title
Walking speed (in m.s-1)
Description
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)
Time Frame
60 days
Title
Range of motion in the lower limbs in degrees
Description
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)
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Ocular fixation time (measured in ms)
Description
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.
Time Frame
60 days
Title
Muscle contractions determined by the electromyogram (EMG) (mV)
Description
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).
Time Frame
60 days
Title
Displacements (in mm) during walking
Description
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).
Time Frame
60 days
Title
Acceleration (in mm.s-2) during walking
Description
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).
Time Frame
60 days
Title
Joint angles
Description
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).
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Lansiaux, MD, PhD
Phone
+33 3 20 22 52 69
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie Hamez
Phone
+33 3 20 22 57 31
Email
hamez.melanie@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Massot, MD
Organizational Affiliation
GHICL
Official's Role
Study Director
Facility Information:
Facility Name
St Vincent hospital - neurological service
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brunno Lenne, PhD
Facility Name
St Philibert hospital - Neurologial service
City
Lomme
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Kwiatkowski, MD
Facility Name
St Philibert hospital - Physical Medicine and Rehabilitation
City
Lomme
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Massot, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Neuropsychological Disorders in Multiple Sclerosis

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