Common and Specific Information From Neuroimaging and Smartphone (MS-CSI)
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|ClinicalTrials.gov Identifier: NCT05482906|
Recruitment Status : Not yet recruiting
First Posted : August 1, 2022
Last Update Posted : August 1, 2022
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Other: eGait|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.|
|Estimated Study Start Date :||September 1, 2022|
|Estimated Primary Completion Date :||November 1, 2024|
|Estimated Study Completion Date :||November 1, 2024|
- Other: eGait
IMU sensor (as part of eGait device) worn at the hip during T25FWOther Name: Wearable sensor
- 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.
- Correlation with disability [ Time Frame: At the inclusion ]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
- Correlation with MRI lesion load [ Time Frame: At the inclusion ]Add lesion load (Spinal and extraspinal lesion volume) from MRI to previous correlation.
- Building a predictive model for lesion load involving in walk ability from IGP [ Time Frame: At the inclusion ]Root mean square error between observed and lesion load predicted by the model, calculated by cross-validation.
- Building a predictive model for group belonging from group established in main outcome based on IGP [ Time Frame: At the inclusion ]Multiclass accuracy between real and predict group, calculated by cross-validation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05482906
|Contact: David LAPLAUD, PHD||33 2 40 16 52 email@example.com|
|Nantes University Hospital|
|Nantes, Loire-Atlantique, France, 44093|