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)

A prospective investigation of the feasibility of smartphone-based self-monitoring to characterize cognitive and neurological impairment in patients with multiple sclerosis (Floodlight MS_More Active)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN62225263

Enrollment

400

Registered

2022-03-11

Start date

2022-07-26

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases

Interventions

- Cohort 1: Participants in Cohort 1 will perform the FL MS Cognitive Test once every week and all other FL MS tests every 2 weeks, MSReactor tests, and Redenlab tests at least once a month and Audio

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 05/11/2025: Cross-sectional correlation between FL MS Cognitive Test vs. ARCS at Baseline and Month 12 Previous primary outcome measure: 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	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 05/11/2025: 1. Longitudinal Correlation Between Change From Baseline to Month 12 on FL MS Cognitive Test vs. ARCS from Baseline up to Month 12 2. Cross-sectional Correlation Between Composite Digital Cognition Outcome vs. ARCS at Baseline and Month 12 3. Longitudinal Correlation Between Change From Baseline to Month 12 in Composite Digital Cognition Outcome vs. ARCS from Baseline up to Month 12 4. FL MS Cognitive Feature Differences at Month 6, Month 12, and Month 18 5. Cross-sectional Hand/Gait vs Expanded Disability Status Scale (EDSS) Assessed Using Spearman Rank-order Correlation at Baseline, Month 6, Month 12, and Month 18 6. Correlation Between FL MS Digital Outcomes (Calculated from Baseline to Month 12) and Subsequent Changes in EDSS 7. In-app FL MS Post-appointment Questionnaire Assessed During Study Period at Baseline, Month 6, and Month 12 8. FL MS Usability Score From mHealth Usability Questionnaire Assessed During Study Period at Baseline, Month 6, Month 12, Month 18, and Month 24 9. Association Between FL MS Digital Outcome and Clinical Relapses up to Month 24 Previous secondary outcome measures as of 21/12/2023: 1. Cross-sectional correlation between composite digital cognition outcome with FL MS and ARCS total score measured using Spearman’s Rank-order Correlation at baseline, Month 12, and Month 24 2. Cross-sectional correlation between FL MS digital cognition outcome and Expanded Disability Status Scale (EDSS) measured using Spearman’s Rank-order Correlation at Months 6, 12, 18 and 24 3. Cross-sectional correlation between digital outcome measures with FL MS and Redenlab score measured using Spearman’s Rank-order Correlation at Months 6, 12, 18 and 24 4. Cross-sectional correlation between digital outcome measures with FL MS and MSReactor Cognitive score measured using Spearman’s Rank-order Correlation at Months 6, 12, 18 and 24 5. Cross-sectional correlation between FL MS digital outcome measures (MS gait	—

Measure

Time frame

Current secondary outcome measures as of 05/11/2025: 1. Longitudinal Correlation Between Change From Baseline to Month 12 on FL MS Cognitive Test vs. ARCS from Baseline up to Month 12 2. Cross-sectional Correlation Between Composite Digital Cognition Outcome vs. ARCS at Baseline and Month 12 3. Longitudinal Correlation Between Change From Baseline to Month 12 in Composite Digital Cognition Outcome vs. ARCS from Baseline up to Month 12 4. FL MS Cognitive Feature Differences at Month 6, Month 12, and Month 18 5. Cross-sectional Hand/Gait vs Expanded Disability Status Scale (EDSS) Assessed Using Spearman Rank-order Correlation at Baseline, Month 6, Month 12, and Month 18 6. Correlation Between FL MS Digital Outcomes (Calculated from Baseline to Month 12) and Subsequent Changes in EDSS 7. In-app FL MS Post-appointment Questionnaire Assessed During Study Period at Baseline, Month 6, and Month 12 8. FL MS Usability Score From mHealth Usability Questionnaire Assessed During Study Period at Baseline, Month 6, Month 12, Month 18, and Month 24 9. Association Between FL MS Digital Outcome and Clinical Relapses up to Month 24 Previous secondary outcome measures as of 21/12/2023: 1. Cross-sectional correlation between composite digital cognition outcome with FL MS and ARCS total score measured using Spearman’s Rank-order Correlation at baseline, Month 12, and Month 24 2. Cross-sectional correlation between FL MS digital cognition outcome and Expanded Disability Status Scale (EDSS) measured using Spearman’s Rank-order Correlation at Months 6, 12, 18 and 24 3. Cross-sectional correlation between digital outcome measures with FL MS and Redenlab score measured using Spearman’s Rank-order Correlation at Months 6, 12, 18 and 24 4. Cross-sectional correlation between digital outcome measures with FL MS and MSReactor Cognitive score measured using Spearman’s Rank-order Correlation at Months 6, 12, 18 and 24 5. Cross-sectional correlation between FL MS digital outcome measures (MS gait

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Countries

Australia

Contacts

Public ContactClinical Trials

global.trial_information@roche.com+41 616878333

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026