A study to investigate the concordance of smartphone-based self-monitoring, imaging, and blood-based biomarkers with clinical disability in participants with multiple sclerosis

Not Applicable

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN11088592
• Lead Sponsor: Roche (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-27
• Last Update Posted: 5 August 2024
• Study Completion: 2024-12-06

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 708

Inclusion Criteria

1. Participant in the TONiC study (with two or more completed TONiC PROM packs)
2. Have a definite diagnosis of MS, confirmed as per the revised McDonald 2017 criteria
3. EDSS of 0.0 to 8.5, inclusive
4. Have a compatible smartphone

Exclusion Criteria

1. Severely ill and unstable participants as per investigator’s discretion
2. Participant incapable of using an app due to neurological impairment as per the investigator’s discretion (i.e. visual impairment, bilateral impaired hand function)
3. For the subset of participants having MRI assessments: unable or unwilling to complete regular MRI
4. For the subset of participants having both biomarker and genetic analysis: unable or unwilling to provide blood samples

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Digital outcomes measured using the Floodlight MS App at baseline and Years 1, 2, and 3<br>2. Upper limb function measured using the 9-hole Peg Test (9HPT) at baseline and years 1, 2, and 3<br>3. Lower limb function measured using the Timed 25-foot Walk Test (T25FWT) at baseline and years 1, 2, and 3<br>4. Neurocognitive function measured using the Symbol Digit Modalities Test (SDMT) at baseline and years 1, 2, and 3