MS CHRONIC PROGRESSIVEEasy EDSSNCT03586635
Automated EDSS Score Calculation by Smartphone Application
An observational study of MS CHRONIC PROGRESSIVE, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MS CHRONIC PROGRESSIVE
- What is being tested?
- neurological exam
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2018to 3 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: - patients coming to the MS Competence and Recovery Centre
Who may be able to join
- 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
Who cannot join
- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients
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.
- Conditions
- MS CHRONIC PROGRESSIVE
- Being tested
- neurological exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | Not described Receives: Other: neurological exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start13 Dec 2018
- Primary completion21 Dec 2020
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS CHRONIC PROGRESSIVEStudies of the same condition, open and under way.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586635
- Sponsor's protocol ID
- 18-PP-09
- Acronym
- Easy EDSS
- Status last verified
- Mar 2022
- First submitted
- 2 Jul 2018
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03586635
- Acronym / sponsor ID
- Easy EDSS / 18-PP-09
- Conditions
- MS CHRONIC PROGRESSIVE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 13 Jul 2018 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | Other: neurological exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - patients coming to the MS Competence and Recovery Centre
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring
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 |
|---|---|---|
| neurological examPatients 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 | Other | Patients with Multiple Sclerosis |
Primary outcome
EDSS score apllication VS paper version
Time frame: 6 months
comparison of the overall EDSS score obtained with the application and its paper version at the end of the neurological examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 MS CHRONIC PROGRESSIVE, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDSS score apllication VS paper version (time frame: 6 months). 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 18 Mar 2022.