Digitalization of Neurofunctional Tests Via a Mobile Application DAMS for Multiple Sclerosis Patients

NCT03148938 | Completed

• 1 other identifier: P005
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 10

Brief Summary

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. 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. 2.The test-retest reliability of DAMS' scores at a 15 day interval

Conditions

Multiple Sclerosis

Keywords

DAM; multiple sclerosis; MSFC; application; mobile

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of DAMS 3 test measured with digital assessment versus MSFC measured with traditional tests.

  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)

  Day 0

Secondary Outcomes (10)

• Diagnostic performance of DAMS 4 tests measured with digital assessment versus MSFC (with vision test) measured with traditional tests

  Day 0

• Diagnostic performance of DAMS 3 tests measured with digital assessment versus MSFC revised measured with traditional tests

  Day 0

• Diagnostic performance of DAMS 4 test measured with digital assessment versus MSFC revised with vision test measured with traditional tests

  Day 0

• Correlation between DAMS 3 tests measured with digital assessment and MSFC measured with traditional tests

  Day 0

• Correlation between DAMS 3 tests measured with digital assessment and MSFC revised measured with traditional tests

  Day 0

Study Arms (2)

Patients with Multiple Sclerosis

EXPERIMENTAL

Patients will perform one or two visits at 15 days interval. Patients will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits.

Other: Digital Assessment on mobile

Healthy volunteer

ACTIVE COMPARATOR

Healthy volunteers will only perform one visit. Healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B).

Other: Digital Assessment on mobile

Interventions

Digital Assessment on mobile OTHER

The digital assessment is composed on 4 tests: * walking test * coordination test * attention test * vision test

Healthy volunteer; Patients with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• MS patients:
• subjects: 18 Years to 60 Years
• with a confirmed and documented MS diagnosis, per the 2010 Revised McDonald criteria
• with or without MS maintenance and/or symptomatic treatment, if MS maintenance and/or symptomatic treatment: stable for the past 6 months before enrolment (Centrally acting antalgics, antidepressant or neuroleptic treatment are authorized but shall not be modified in the past 2 months before enrolment)
• with an EDSS \[0;7\] in the past 6 months before enrolment
• with an EDSS \[0;7\] in the past 6 months before enrolment
• with no evidence of EDSS score change since the last measure available
• with no evidence of relapse in the past 6 months before enrolment
• enrolled in or benefiting of a Social Security program
• who have read the information sheet and signed the informed consent form
• Healthy volunteers:
• subjects: 18 Years to 60 Years
• with no evidence of walk limitation (as per clinician's judgment) nor walking aid
• no personal and familial history of inflammatory disease (e.g. rheumatoid arthritis) or multiple sclerosis
• matched to the sociodemographic characteristics of MS patients sample (age, sex, height, weight, education)

You may not qualify if:

• Patient experiencing a relapse once enrolled in the study
• Patient with a maintenance and symptomatic MS treatment modification
• Use of centrally acting antalgics, antidepressant or neuroleptic once enrolled in the study
• Omission or change in the usual visual and/or walking aids
• Acute asthenia (score\>7 on a visual analogic scale) at the follow-up visit.

Sponsors & Collaborators

• Ad scientiam: lead

Study Sites (10)

Hôpital le Bocage

Dijon, France

Location

Hôpital Saint-Phllibert

Lille, France

Location

Hôpital La Timone Adulte

Marseille, France

Location

Hôpital Gui de Chauliac

Montpellier, France

Location

Hôpital Pasteur

Nice, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Hôpital Maison Blanche

Reims, France

Location

Hôpital Saint Hélier

Rennes, France

Location

Hôpital Charles Nicolle

Rouen, France

Location

Hôpital Hautepierre

Strasbourg, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Elisabeth MAILLART, MD

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will perform one or two visits at 15 days interval. Healthy volunteers will only perform one visit. Patients and healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 11, 2017
• Study Start: October 2, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 29, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-07

Locations

FR (10)