G35.1
Conditions
Interventions
Group 1: Baseline-Visit
At baseline, baseline characteristics are recorded. This is done on the one hand by examinations during the study visit at the study center (A), by surveys from the outpatient
Sponsors
Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center (NCRC)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participant’s age is = 18 years - Participant resides within reasonable range from study center to allow technical set-up and back-up at home in person, if required - Written informed consent to participate in this study - Diagnosis of relapsing-remitting multiple sclerosis according to 2017 diagnostic criteria (Thompsen AJ, et al., 2017) AND - Disease duration of <10 years since diagnosis AND - EDSS = 6.0 (ability to perform short walking tests with only unilateral assistance) AND - fulfilment of one or more of the following criteria: o history of recent disease activity: = 1 relapse or = 1 new T2 lesion or = 1 Gd+ enhancing lesion on MRI over the past two years OR o Findings on routine brain MRI from within 6 months prior to screening: total T2 lesion load of = 10 OR o Findings on routine brain MRI from within 6 months prior to screening: any Gd+ enhancing lesion OR o Findings on routine MRI from within 6 months prior to screening: = 1 spinal or brainstem lesion OR o Finding on optical coherence tomography performed at screening: pRNFL < 92µm in a non-ON eye
Exclusion criteria
Exclusion criteria: - Relapse within 3 months prior to baseline visit - Other disease or condition with suspected effect on motor performance - Any condition foreseen to prevent compliance with protocol - The patient is pregnant at screening - Any contra-indications for MRI investigation at screening If pregnancy or incident contra-indications for MRI occur after Baseline, participant may still be followed up with respect to primary endpoint, but MRI investigation will be omitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of an instrumental definition of confirmed disease progression in early multiple sclerosis by patient self-assessment of motor symptoms using a consumer-grade device for visual-perceptive motion capture applied every 6 months in the home setting. Primary criterion for validity is comparison against current definitions of EDSS progression confirmed at 3 months (3m-CDP). | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression defined by home-based short motor assessment in relation to alternative definitions of disease progression or stability in early multiple sclerosis after 24 months. | — |
Countries
Germany
Contacts
Public ContactEva-Maria Dorsch
Charité - Campus Benjamin Franklin
Outcome results
None listed