Digital Assessment on mobile
OtherThe digital assessment is composed on 4 tests:
- walking test
- coordination test
- attention test
- vision test
NCT Number: NCT03148938
Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. The Digital self-Assessment for Multiple sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and clinically validated remote monitoring platform for MS patients and clinicians. The correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30 subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test had a poor reproducibility and clinicians expressed the wish to measure a walking range rather than a walking speed. Even though vision is the main sense impacting all other tests, particularly when interacting with a mobile, visual tests are rarely performed in real life. A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).
The hypothesis is that systematic and prospective multi-dimensional data collection of MS disabilities through the DAMS mobile application will refine the quality and accuracy of both clinicians and patients' knowledge of the disease progression and will ultimately improve the current care of patients.
To test this assumption, the statistician will analyze:
1. The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests) the low contrast vision test versus standard MS scales 2. The test-retest reliability of DAMS' scores at a 15 day interval
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Hôpital le Bocage, Dijon, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
MS patients:
Healthy volunteers:
Non-Inclusion Criteria:
MS patients and Healthy volunteers:
Exclusion criteria
The digital assessment is composed on 4 tests:
Time frame: Day 0
Determine the diagnostic performance of DAMS 3 tests (not included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDDSS) score [0;7]) compared to the traditional tests (MSFC)
Time frame: Day 0
Determine the diagnostic performance of DAMS 4 tests (included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDSS) score [0;7]) compared to the conventional MSFC + Sloan low contrast letter acuity test
Time frame: Day 0
Determine the diagnostic performance of DAMS 3 tests for the detection of MS patients in a population of healthy volunteers and MS patients (with EDSS score [0;7]) compared to a revised form of MSFC in which PASAT has been replaced by SDMT
Time frame: Day 0
Determine the diagnostic performance of DAMS 4 tests for the detection of MS patients in a population of healthy volunteers and MS patients (with EDSS score [0;7]) compared to a revised form of MSFC in which PASAT has been replaced by SDMT and SLCLAT added.
Time frame: Day 0
To assess correlation between DAMS 3 tests and MSFC in MS patients and healthy volunteers
Time frame: Day 0
To assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT in MS patients and healthy volunteers
Time frame: Day 0
To assess correlation between DAMS 4 tests and MSFC with vision test result in MS patients and healthy volunteers
Time frame: Day 0
o assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT with vision test result in MS patients and healthy volunteers
Time frame: Day 0
To compare the scores obtained with each DAMS' evaluation test [mobile walking test, coordination test, attention test, vision test ] to those obtained with traditional tests (T25FW, 9-HPT, PASAT, SDMT, SLCLAT) in MS patients and healthy volunteers
Time frame: Day 15
To assess the test-retest reliability of DAMS 3 and 4 tests during the study in MS patients with EDSS score [0;7]
Time frame: Day 15
Ad scientiam
Other
" Digitalization of Neurofunctional Tests Via a Mobile Application, Digital Assessment Multiple Sclerosis (DAMS), for Multiple Sclerosis Patients"
Acronym: MSCopilot
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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