Optimizing detection and prediction of cognitive function in multiple sclerosis with ambulatory cognitive tests: Protocol for the longitudinal observational “CogDetect-MS” study (Preprint)

Abstract

BACKGROUND Cognitive dysfunction is a common, distressing, and disabling problem in multiple sclerosis (MS). Progress toward understanding and treating cognitive dysfunction is thwarted by limitations of traditional clinic or lab-based cognitive tests, which suffer from poor sensitivity to change and ecological validity. Ambulatory methods of assessing cognitive function in the lived environment offer the potential to improve detection of subtle changes in cognitive function in MS and better understand the predictors of cognitive changes and downstream effects of cognitive change on other functional domains. OBJECTIVE This paper describes the study design and protocol for the CogDetect-MS study, a 2-year longitudinal observational study designed to examine short- and long-term changes in cognition, predictors of cognitive change, and effects of cognitive change on social and physical function in people with MS. METHODS Participants – ambulatory adults ages 18 years or older with medically documented MS - are assessed over the course of two years on an annual basis (three assessments total: T1, T2, T3). A comprehensive survey battery, in-lab cognitive and physical performance tests, and 14 days of ambulatory data collection are completed at each annual assessment. The 14-day ambulatory data collection includes continuous wrist-worn accelerometry (to measure daytime activity and sleep) and ecological momentary assessments (real-time self-report) of somatic symptoms, mood, and contextual factors and 2 brief, validated cognitive tests, administered by smartphone app 4 times per day. Our aim was to recruit 250 adults with MS. RESULTS The study has recruited and collected T1 data from N=260 adults with MS. Follow-up data collection will continue through March 2026. CONCLUSIONS Results from the CogDetect-MS study will shed new light on the temporal dynamics of cognitive function, somatic and mood symptoms, sleep, physical activity, and physical and social function. These insights have the potential to improve our understanding of changes in cognitive function in MS and enable us to generate new interventions to maintain or improve cognitive function in those with MS. CLINICALTRIAL NCT05252195