NCT03586635

Brief Summary

The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies. Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature. The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

July 2, 2018

Last Update Submit

March 17, 2022

Conditions

MS CHRONIC PROGRESSIVE

Outcome Measures

Primary Outcomes (1)

  • EDSS score apllication VS paper version

    comparison of the overall EDSS score obtained with the application and its paper version at the end of the neurological examination

    6 months

Study Arms (1)

Patients with Multiple Sclerosis

Other: neurological exam

Interventions

neurological examOTHER

Patients participating in the study are recruited from the investigator's tertiary multiple sclerosis management centre. They are systematically examined neurologically as part of their routine follow-up. the patient will be exceptionally examined by two distinct persons, a senior doctor and a junior doctor (internal or external) independently. At the end of the neurological examination, each examiner will evaluate the EDSS score in a classical way (using paper definitions) then using the smartphone application

Patients with Multiple Sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- patients coming to the MS Competence and Recovery Centre

You may qualify if:

  • Patients with multiple sclerosis seen at the Central Nervous System Day Hospital as part of their follow-up and requiring neurological examination.
  • Age ≥ 18 years
  • No opposition to the use of their data

You may not qualify if:

  • \- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

Study Design

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

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 13, 2018

Study Start

December 13, 2018

Primary Completion

December 21, 2020

Study Completion

September 3, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)