Common and Specific Information From Neuroimaging and Smartphone

NCT05482906 | Recruiting

• 1 other identifier: RC20_0203
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).

Conditions

Multiple Sclerosis

Keywords

Wearable sensor; Gait; MRI

Outcome Measures

Primary Outcomes (3)

• Clustering analyze based on IGP

  IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle (0-1).

  At the inclusion

• Clustering analyze based on EDSS score

  EDSS is an ordinal scale measuring disability and ranging from 0 (normal examination) to 10 (death due to MS) in a 0,5-point increments from score 1.

  At the inclusion

• Clustering analyze based on MRI lesion load

  MRI characteristics are spinal and extraspinal lesion volumes.

  At the inclusion

Secondary Outcomes (4)

• Correlation with disability

  At the inclusion

• Correlation with MRI lesion load

  At the inclusion

• Building a predictive model for lesion load involving in walk ability from IGP

  At the inclusion

• Building a predictive model for group belonging from group established in main outcome based on IGP

  At the inclusion

Interventions

eGait OTHER

IMU sensor (as part of eGait device) worn at the hip during T25FW

Also known as: Wearable sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS patients cohort followed at Nantes university hospital or Rennes university hospital (OFSEP HD cohort)

You may qualify if:

• Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
• Over 18 years old /age greater than 18 years
• Patients followed at Nantes university hospital or Rennes university hospital
• No relapse within 3 months
• With a Medullar MRI planed as part as usual care
• MRI scan can be performed within a maximum of 4 months after or before the walking test.
• Affiliated person or beneficiary of a social security scheme

You may not qualify if:

• Bilateral aid needed to walk
• Women who are pregnant
• Patient having expressed their opposition
• Patient under guardianship or security measure

Sponsors & Collaborators

• Nantes University Hospital: lead
• Rennes University Hospital: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

David LAPLAUD, PHD

CONTACT

33 2 40 16 52 00; david.laplaud@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 1, 2022
• Study Start: April 3, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)