Objective: To determine the reliability and convergent validity of a novel digital monitoring platform offering objective, daily assessment of cognitive and motor symptom severity in HD.

Background: Longitudinal monitoring of HD signs and symptoms through frequent, home-based testing promises to enhance standard clinical testing methods that are potentially limited by natural symptom fluctuations, inter-rater variability and subjectivity. A preliminary analysis of the ongoing RG6042 open-label extension study (OLE) (NCT03342053) demonstrated that frequent remote monitoring yields reliable and valid measures of cognition and motor symptoms in HD when compared with established clinical measures [1].

Method: The Roche HD Digital monitoring platform includes a smartphone application with seven active tests (Symbol Digit Modalities Test [SDMT], Stroop Word Reading, Speeded tapping, Chorea, Balance, U-turn, and 2-minute walk test) and continuous passive monitoring. This platform is used in an ongoing, natural history study in patients with Stage I/II HD (NCT03664804). A cross-sectional baseline analysis will be conducted. We will extract predefined sensor features (e.g. number of correct responses on the SDMT and U-Turn turn speed) from active tests and passive monitoring, as carried out in a cross-sectional baseline analysis with a similar HD population (RG6042 OLE [1]). Features will be averaged from all tests performed over a 2-week period and compared with standard clinical measures at baseline. Intra-class correlation coefficients and Spearman correlations will be used to quantify test-retest reliability, and convergent validity of novel digital measures compared with equivalent standard in-clinic tests.

Results: We will report on preliminary adherence to demonstrate acceptance and feasibility of the approach. We will evaluate the test-retest reliabilities of active test features and compare with those collected in a separate study. Results will be reported for correlations of digital test features with related clinical scores.

Conclusion: Further evidence of the feasibility, validity, and reliability and agreement between digital and established clinical measures will support continued use of frequent remote digital monitoring measures of cognitive and motor symptom severity in patients with HD.

References: 1. Lipsmeier F, et al. Neurology. In press; Presented at American Academy of Neurology 2019 Annual Meeting.

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/reliability-feasibility-and-validity-of-a-novel-digital-monitoring-platform-assessing-cognitive-and-motor-symptoms-in-people-with-stage-i-and-ii-huntingtons-disease-hd/