A study to investigate the feasibility of smartphone-based self-monitoring to characterise cognitive and neurological impairment in participants with multiple sclerosis (Floodlight MS_More Active)

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN62225263
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-11
• Study Completion: 2024-07-31
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

Current participant inclusion criteria as of 21/12/2023:
1. Be able to provide informed consent to the study, and to participate in the MSBase registry and the MRI repository
2. Aged 18 years or older
3. EDSS in the range of 1.0 to 7.0 inclusive
4. Diagnosis of MS (new or revised) based on the 2017 revised McDonald criteria
5. Untreated or treated with an approved or off-label DMT, if DMT was initiated >3 months ago
6. Must have a personal smartphone
7. Willing to discontinue participation in any other Floodlight application.

Previous participant inclusion criteria:
1. Be able to provide informed consent to the study, and to participate in the MSBase registry and the MRI repository
2. Aged 18 years or older
3. EDSS in the range of 2.0 to 7.0 inclusive
4. Diagnosis of MS (new or revised) based on the 2017 revised McDonald criteria
5. Untreated or treated with an approved or off-label DMT, if DMT was initiated >3 months ago
6. Must have a personal smartphone
7. Willing to discontinue participation in any other Floodlight application.

Exclusion Criteria

1. Unable to provide data to establish a minimum dataset
2. Any contraindication for use of smartphone as per the investigator’s discretion
3. Known significant cognitive impairment as per the investigator’s discretion
4. Not able to tolerate routine clinical MRI
5. Clinical relapse in the 30 days before enrolment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cross-sectional correlation between FL MS Cognitive Test outcome and ARCS total outcome measured using Spearman’s Rank-order Correlation at baseline, Month 12, and Month 24