Concordance of app, MR & biomarkers with clinical disability in MS
Research type
Research Study
Full title
A prospective investigation of the concordance of smartphone-based self monitoring, imaging, and blood-based biomarkers with clinical disability in patients with multiple sclerosis within the TONiC program
IRAS ID
305058
Contact name
Carolyn A. Young
Contact email
Sponsor organisation
Roche
ISRCTN Number
ISRCTN11088592
Duration of Study in the UK
5 years, 11 months, 30 days
Research summary
The traditional method of disability measurement for people with multiple sclerosis (pwMS) uses clinical examination; this has the limitations of relying on just one assessment, at a time that may not be representative, and omits many disabling symptoms which cannot be detected by examination, such as fatigue, pain, or anxiety. Recent research shows several benefits of assessment using Patient Reported Outcome Measures (PROMs), including measurement of symptoms such as fatigue or pain, and asking respondents how their daily activities are affected. Nowadays apps are available online, which can be downloaded to a smartphone and used for self monitoring by pwMS. We hypothesise that each of these different assessment methods can contribute to a deeper understanding of disability but do not know yet how to inter-relate these assessment methods. Furthermore, some centres are exploring the use of proxy measures of assessing disability, such as MR imaging or a blood test to check the level of biomarkers believed to reflect nerve damage. In this study we will create an integrated dataset of different ways of measuring disability, to explore their inter-relationships.
Participants with MS who are already taking part in a PROM-based follow up study called Trajectories of Outcome in Neurological Conditions (TONiC) are eligible to join this study for up to 4 years. All subjects will be invited to use a smartphone app called Floodlight MS each week, as well as having routine annual review at their normal MS centre, including clinical assessment. One thousand MS patients will be included, 500 will have MR imaging and blood biomarkers at baseline of whom 300 will have repeat imaging at years 2 and 4 and repeat biomarkers at years 1, 2 and 4. A subset of 300 pwMS will be asked to donate additional blood samples twice for exploratory analyses such as CyTOF.REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0900
Date of REC Opinion
2 Feb 2022
REC opinion
Further Information Favourable Opinion