Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
1000 subjects with multiple sclerosis actively enrolled in the TONiC observational study at participating UK-based TONiC site(s) will be prospectively evaluated for correlations between digital outcom
Sponsors
Roche (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Digital outcomes measured using the Floodlight MS App at baseline and Years 1, 2, and 3 2. Upper limb function measured using the 9-hole Peg Test (9HPT) at baseline and years 1, 2, and 3 3. Lower limb function measured using the Timed 25-foot Walk Test (T25FWT) at baseline and years 1, 2, and 3 4. Neurocognitive function measured using the Symbol Digit Modalities Test (SDMT) at baseline and years 1, 2, and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Longitudinal digital outcomes measured weekly using the Floodlight MS App from baseline to Year 3 2. Neurologic impairment measured using the Expanded Disability Status Scale (EDSS) at baseline and years 1, 2, and 3 3. Visual function measured using the low-contrast visual acuity (LCVA) at baseline and years 1, 2, and 3. LCVA is scored as the total number of correct letters on a 2.5% contrast Sloan chart positioned at a 2-metre distance from the patient’s eyes. 4. Time to onset of Confirmed Disability Progression (CDP) for at least 48 weeks during the study period (time frame: 4 years). Disability progression is defined as an increase in the EDSS score of =1.5 points if the initial EDSS is 0, an increase of =1.0 point if the initial EDSS is >0 to = 5.5, or an increase of =0.5 points if the initial EDSS is >5.5. 5. Time to onset of Confirmed Disability Improvement (CDI) for at least 48 weeks during the study period (time frame: 4 years). Disability improvement is defined as a decrease of =1.0 point if the initial EDSS is 2.0–5.5, or a decrease of =0.5 points if the initial EDSS is >5.5. 6. Time to onset of confirmed worsening of upper limb function for at least 48 weeks (time frame: 4 years). Worsening of upper limb function is defined as a 20% increase on the 9HPT. 7. Time to onset of confirmed improvement of upper limb function for at least 48 weeks (time frame: 4 years). Improvement of upper limb function is defined as a 20% decrease on the 9HPT. 8. Time to onset of confirmed worsening of lower limb function for at least 48 weeks (time frame: 4 years). Worsening of upper limb function is defined as a 20% increase on the T25FWT 9. Time to onset of confirmed improvement of lower limb function for at least 48 weeks (time frame: 4 years). Improvement of upper limb function is defined as a 20% decrease on the T25FWT. 10. Time to onset of confirmed worsening of neurocognitive function for at least 48 weeks (time frame: 4 years). Worsening of neurocognitive function | — |
Countries
England, United Kingdom
Contacts
Public ContactClinical Trials
Outcome results
None listed