Objective: To test the feasibility and validity of digital mobility data for enrichment of the prodromal screening and to assess the sensitivity of these measures to early phase progression in prodromal and recently diagnosed patients with Parkinson’s disease (PD).

Background: PPMI places great emphasis on identifying prodromal cohorts. Despite the centrality of motor dysfunction in PD, current motor assessment largely relies on clinical rating scales lacking sensitivity to subtle motor changes in the prodromal stage. Previous work using digital technology and wearable sensors was able to capture subtle gait and mobility changes approximately 3-4 years prior to diagnosis. Building on this work, the digital mobility sub-study will augment the digital platform utilized in PPMI focusing on gait and mobility both in-clinic and in the home environment.

Method: Two-hundred prodromal subjects enrolled in PPMI will be invited to participate in this longitudinal sub-study.  Assessments will be performed annually over 3 years. During the in-clinic visit, participants will undergo a structured gait assessment while fitted with 3 wireless wearable sensors on both wrists and on the lower back (Opals, APDM Ltd.).  The protocol includes the Timed Up and Go test and two walking trials (preferred speed and dual task) each of 1 minute. Participants will also receive an additional sensor (Axivity Ltd.  AX6) to be worn on their lower back for continuous monitoring (24/7) for one week.  This group is estimated to include 75% DAT positive and 25% DAT negative participants enabling to evaluate differences in progression. We will also recruit 50 recently diagnosed patients with PD (<2 yrs) and 50 healthy controls to undergo the same protocol. These subjects will serve as reference groups for the analysis of gait in the prodromal stage.

Results: The first participant was recruited on March 1^st 2023. Interim analysis is planned after 50 participants are included.

Conclusion: Digital technology is rapidly entering clinical medicine and clinical research as a technology capable of accurately capturing multiple mobility functions. While a number of efforts in this domain are in progress, important gaps remain including validation in prodromal disease, longitudinal progression, variance and modifiers. This sub-study aims to help close some of these gaps.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/digital-mobility-sub-study-in-the-parkinsons-progressive-marker-initiative-ppmi-study/