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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Digital Assessment on mobile
Sponsored by
Ad scientiam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring DAM, multiple sclerosis, MSFC, application, mobile

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)
  • enrolled in or benefiting of a Social Security program
  • who have read the information sheet and signed the informed consent form

Non-Inclusion Criteria:

MS patients and Healthy volunteers:

  • Participants wearing pacemakers, implantable defibrillators, or hearing aids
  • Inability to use their right hand for the Coordination test (MCT)
  • Evidence of neurologic or psychiatric disorder other than MS, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive functioning
  • Evolutive rheumatology disease
  • Any vision (ex. short-sightedness (-6; +6); congenital dyschromatopsia and glaucoma) or hearing conditions that could influence the performing of the tests
  • Omission of the usual visual and/or walking aids if it's usually needed
  • Acute asthenia (score>7 on a visual analogic scale)
  • Systemic corticosteroid treatment in the past 30 days before enrolment
  • Intramuscular botulinic toxin injection in the past 4 months before enrolment
  • Change in centrally acting antalgic, antidepressant or neuroleptic treatment in the past 2 months before enrolment
  • Rehabilitation in the past 6 months before enrolment
  • Pregnant and nursing women - Person under guardianship or curatorship
  • Bedridden patients or patients with a daily activity of less than 2 hours per day
  • Inability to use a mobile application
  • Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
  • Participation to another study Healthy volunteers who will not match the sociodemographic characteristics of MS patients will not be included in the study.

Exclusion Criteria:

  • 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
  • Substance or/and alcohol abuse that could influence performance on the tests between inclusion and follow-up visits (clinician's judgement)
  • 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.

Sites / Locations

  • Hôpital le Bocage
  • Hôpital Saint-Phllibert
  • Hôpital La Timone Adulte
  • Hôpital Gui de Chauliac
  • Hôpital Pasteur
  • Hôpital Pitié Salpêtrière
  • Hôpital Maison Blanche
  • Hôpital Saint Hélier
  • Hôpital Charles Nicolle
  • Hôpital Hautepierre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with Multiple Sclerosis

Healthy volunteer

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Diagnostic performance of DAMS 4 tests measured with digital assessment versus MSFC (with vision test) measured with traditional tests
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
Diagnostic performance of DAMS 3 tests measured with digital assessment versus MSFC revised measured with traditional tests
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
Diagnostic performance of DAMS 4 test measured with digital assessment versus MSFC revised with vision test measured with traditional tests
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.
Correlation between DAMS 3 tests measured with digital assessment and MSFC measured with traditional tests
To assess correlation between DAMS 3 tests and MSFC in MS patients and healthy volunteers
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised measured with traditional tests
To assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT in MS patients and healthy volunteers
Correlation between DAMS 4 tests measured with digital assessment and MSFC with vision test measured with traditional tests
To assess correlation between DAMS 4 tests and MSFC with vision test result in MS patients and healthy volunteers
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised with vision test measured with traditional tests
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
Compare scores of digital assessment versus scores of traditional tests
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
Compare scores of digital assessment at day 0 versus 15 days later
To assess the test-retest reliability of DAMS 3 and 4 tests during the study in MS patients with EDSS score [0;7]
Safety of Mobile assessment with the collect of all the adverse events

Full Information

First Posted
May 5, 2017
Last Updated
September 13, 2018
Sponsor
Ad scientiam
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1. Study Identification

Unique Protocol Identification Number
NCT03148938
Brief Title
Digitalization of Neurofunctional Tests Via a Mobile Application DAMS for Multiple Sclerosis Patients
Acronym
MSCopilot
Official Title
" Digitalization of Neurofunctional Tests Via a Mobile Application, Digital Assessment Multiple Sclerosis (DAMS), for Multiple Sclerosis Patients"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ad scientiam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests) the low contrast vision test versus standard MS scales The test-retest reliability of DAMS' scores at a 15 day interval

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
DAM, multiple sclerosis, MSFC, application, mobile

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Multiple Sclerosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy volunteer
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Digital Assessment on mobile
Intervention Description
The digital assessment is composed on 4 tests: walking test coordination test attention test vision test
Primary Outcome Measure Information:
Title
Diagnostic performance of DAMS 3 test measured with digital assessment versus MSFC measured with traditional tests.
Description
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
Secondary Outcome Measure Information:
Title
Diagnostic performance of DAMS 4 tests measured with digital assessment versus MSFC (with vision test) measured with traditional tests
Description
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
Title
Diagnostic performance of DAMS 3 tests measured with digital assessment versus MSFC revised measured with traditional tests
Description
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
Title
Diagnostic performance of DAMS 4 test measured with digital assessment versus MSFC revised with vision test measured with traditional tests
Description
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
Title
Correlation between DAMS 3 tests measured with digital assessment and MSFC measured with traditional tests
Description
To assess correlation between DAMS 3 tests and MSFC in MS patients and healthy volunteers
Time Frame
Day 0
Title
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised measured with traditional tests
Description
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
Title
Correlation between DAMS 4 tests measured with digital assessment and MSFC with vision test measured with traditional tests
Description
To assess correlation between DAMS 4 tests and MSFC with vision test result in MS patients and healthy volunteers
Time Frame
Day 0
Title
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised with vision test measured with traditional tests
Description
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
Title
Compare scores of digital assessment versus scores of traditional tests
Description
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 0
Title
Compare scores of digital assessment at day 0 versus 15 days later
Description
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
Title
Safety of Mobile assessment with the collect of all the adverse events
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) enrolled in or benefiting of a Social Security program who have read the information sheet and signed the informed consent form Non-Inclusion Criteria: MS patients and Healthy volunteers: Participants wearing pacemakers, implantable defibrillators, or hearing aids Inability to use their right hand for the Coordination test (MCT) Evidence of neurologic or psychiatric disorder other than MS, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive functioning Evolutive rheumatology disease Any vision (ex. short-sightedness (-6; +6); congenital dyschromatopsia and glaucoma) or hearing conditions that could influence the performing of the tests Omission of the usual visual and/or walking aids if it's usually needed Acute asthenia (score>7 on a visual analogic scale) Systemic corticosteroid treatment in the past 30 days before enrolment Intramuscular botulinic toxin injection in the past 4 months before enrolment Change in centrally acting antalgic, antidepressant or neuroleptic treatment in the past 2 months before enrolment Rehabilitation in the past 6 months before enrolment Pregnant and nursing women - Person under guardianship or curatorship Bedridden patients or patients with a daily activity of less than 2 hours per day Inability to use a mobile application Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment) Participation to another study Healthy volunteers who will not match the sociodemographic characteristics of MS patients will not be included in the study. Exclusion Criteria: 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 Substance or/and alcohol abuse that could influence performance on the tests between inclusion and follow-up visits (clinician's judgement) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth MAILLART, MD
Organizational Affiliation
Pitié-Salpêtrière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital le Bocage
City
Dijon
Country
France
Facility Name
Hôpital Saint-Phllibert
City
Lille
Country
France
Facility Name
Hôpital La Timone Adulte
City
Marseille
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
Country
France
Facility Name
Hôpital Pasteur
City
Nice
Country
France
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
Country
France
Facility Name
Hôpital Maison Blanche
City
Reims
Country
France
Facility Name
Hôpital Saint Hélier
City
Rennes
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
Hôpital Hautepierre
City
Strasbourg
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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