Assessing fatigue, disease activity and progression through smartphone surveillance in multiple sclerosis

Recruiting

Conditions: MS
Multiple sclerosis
10012303

Registration Number: NL-OMON46691

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

- Age between 18 and 65 years.
- Diagnosis of MS (revised McDonald 2017 criteria)
- Regular usage of a smartphone with iOS 10 (or higher) or Android 5.0 (or
higher), front-facing camera, and minimal screen size of 3.7 inches or 9.4
centimeters.

Exclusion Criteria

- EDSS 7.5 or higher at baseline screening.
- Clinical or radiological disease activity or changes in disease modifying
drugs two months prior to baseline screening.
- Clinically relevant visual disturbances
- Confirmed (history of) relevant mood disorders, and symptoms of the mood
disorder at baseline screening
- Co-morbid sleeping disorders

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Fatigue: mobile application metrics (NeuroKeys and MS sherpa) and clinical<br /><br>outcomes (FSS, Fatigue Severity Scale; CIS20R, Checklist Individual Strength;<br /><br>and MFIS, Modified Fatigue Impact Scale).<br /><br>- Disease activity: mobile application metrics (NeuroKeys and MS Sherpa) and<br /><br>clinical outcomes (occurrence of MS relapse, new or enlarging T2 lesions, T1<br /><br>gadolinium (Gd)-enhancing lesions).<br /><br>- Disease progression: mobile application metrics (NeuroKeys and MS Sherpa) and<br /><br>clinical outcomes (EDSS, Expanded Disability<br /><br>Status Scale; MSFC, Multiple Sclerosis Functional Composite; BICAMS, Brief<br /><br>International Cognitive Assessment for MS; AMSQ, Arm function in Multiple<br /><br>Sclerosis Questionnaire; retinal nerve fibre layer and ganglion cell<br /><br>layer-inner plexiform layer thickness, brain volume).</p><br>

Secondary Outcome Measures