Multiple SclerosisMS-CSINCT05482906
Common and Specific Information From Neuroimaging and Smartphone
An observational study of Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- eGait
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: MS patients cohort followed at Nantes university hospital or Rennes university hospital (OFSEP HD cohort)
Who may be able to join
- 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
- Last known EDSS before inclusion ranging from 0 to 6 inclusive/EDSS of 0 to 6 inclusive, prior inclusion
- 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
Who cannot join
- Bilateral aid needed to walk
- Women who are pregnant
- Patient having expressed their opposition
- Patient under guardianship or security measure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
About this study
Official title: Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.
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).
Read the detailed description
This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue previous works conducted on (IGP to assess) gait alteration in MS by adding (to IGP) new information from MRI.
- Conditions
- Multiple Sclerosis
- Being tested
- eGait
- Keywords
- Wearable sensor, Gait, MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eGaitOther
Also called Wearable sensor
IMU sensor (as part of eGait device) worn at the hip during T25FW
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At the inclusion
Clustering analyze based on MRI lesion load
MRI characteristics are spinal and extraspinal lesion volumes.
Measured: At the inclusion
Secondary outcomes (4)
Correlation with disability
Correlation of IGP obtained during a walk of 25 feet with Expanded Disability Status Scale (EDSS). 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. Here EDSS of 0 to 2 inclusive defined as mild, 2,5 to 4 inclusive as moderate and EFDSS of 4,5 to 6 inclusive defined as severe
Measured: At the inclusion
Correlation with MRI lesion load
Add lesion load (Spinal and extraspinal lesion volume) from MRI to previous correlation.
Measured: At the inclusion
Building a predictive model for lesion load involving in walk ability from IGP
Root mean square error between observed and lesion load predicted by the model, calculated by cross-validation.
Measured: At the inclusion
Building a predictive model for group belonging from group established in main outcome based on IGP
Multiclass accuracy between real and predict group, calculated by cross-validation
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start3 Apr 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482906
- Sponsor's protocol ID
- RC20_0203
- Acronym
- MS-CSI
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2022
- Last updated
- 13 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT05482906
- Acronym / sponsor ID
- MS-CSI / RC20_0203
- Conditions
- Multiple Sclerosis
- Keywords
- Wearable sensor, Gait, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Rennes University Hospital
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Aug 2022 (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.
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).
Detailed description
This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue previous works conducted on (IGP to assess) gait alteration in MS by adding (to IGP) new information from MRI.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- MS patients cohort followed at Nantes university hospital or Rennes university hospital (OFSEP HD cohort)
Key inclusion criteria (8 listed)
- 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
- Last known EDSS before inclusion ranging from 0 to 6 inclusive/EDSS of 0 to 6 inclusive, prior inclusion
- No relapse within 3 months
Key exclusion criteria (4 listed)
- Bilateral aid needed to walk
- Women who are pregnant
- Patient having expressed their opposition
- Patient under guardianship or security measure
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 |
|---|---|---|
| eGaitAlso: Wearable sensorIMU sensor (as part of eGait device) worn at the hip during T25FW | Other | – |
Primary outcome
Clustering analyze based on IGP
Time frame: At the inclusion
IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle (0-1).
Clustering analyze based on EDSS score
Time frame: At the inclusion
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.
Clustering analyze based on MRI lesion load
Time frame: At the inclusion
MRI characteristics are spinal and extraspinal lesion volumes.
4 secondary outcomes
Correlation with disability
Time frame: At the inclusion
Correlation with MRI lesion load
Time frame: At the inclusion
Building a predictive model for lesion load involving in walk ability from IGP
Time frame: At the inclusion
Building a predictive model for group belonging from group established in main outcome based on IGP
Time frame: At the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Nantes University Hospital at 1 site 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David LAPLAUD, PHD (33 2 40 16 52 00, david.laplaud@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clustering analyze based on IGP (time frame: At the inclusion). The study lists 3 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 13 Mar 2026.