A Multicenter Study Using a Smartwatch, Smartphone, and Wearable Sensors to Assess Early Parkinson’s Disease: Baseline Results of the WATCH-PD Study

Adams, Jamie L.; Kangarloo, Tairmae; Tracey, Brian H.; O’Donnell, Patricio; Volfson, Dmitri; Latzman, Robert D.; Zach, Neta; Alexander, Robert; Bergethon, Peter; Cosman, Joshua D.; Anderson, David G.; Best, Allen; Kostrzebski, Melissa; Wilmot, Peter; Pohlson, Yvonne; Waddell, Emma; Jensen-Roberts, Stella; Gong, Yishu; Kilambi, Krishna Praneeth; Herrero, Teresa Ruiz; Dorsey, E. Ray

doi:10.21203/rs.3.rs-2289246/v1

Cited by 4 publications

(5 citation statements)

References 52 publications

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“…As with clinical outcome measures, digital outcome development is a vibrant, fast changing field with an increasing need to close the gap between digital innovation and validation of measures to clinical trial standards [46,48]. Initiatives such as WATCH-PD as well as incorporation of digital measures as exploratory endpoints in trials are important to drive digital outcome development forward [49]. Whilst passive digital measures were endorsed by the panel, no consensus was reached on active measures.…”

Section: Discussionmentioning

confidence: 99%

An International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson’s Disease Trials

Zeissler,

McFarthing,

Raphael

et al. 2023

JPD

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Background: Design of disease modification (DM) trials for Parkinson’s disease (PD) is challenging. Successful delivery requires a shared understanding of priorities and practicalities. Objective: To seek stakeholder consensus on phase 3 trials’ overall goals and structure, inclusion criteria, outcome measures, and trial delivery and understand where perspectives differ. Methods: An international expert panel comprising people with Parkinson’s (PwP), care partners (CP), clinical scientists, representatives from industry, funders and regulators participated in a survey-based Delphi study. Survey items were informed by a scoping review of DM trials and PwP input. Respondents scored item agreement over 3 rounds. Scores and reasoning were summarized by participant group each round until consensus, defined as≥70% of at least 3 participant groups falling within the same 3-point region of a 9-point Likert scale. Results: 92/121 individuals from 13 countries (46/69 PwP, 13/18 CP, 20/20 clinical scientists, representatives from 8/8 companies, 4/5 funders, and 1/1 regulator) completed the study. Consensus was reached on 14/31 survey items: 5/8 overall goals and structure, 1/8 Eligibility criteria, 7/13 outcome measures, and 1/2 trial delivery items. Extent of stakeholder endorsement for 428 reasons for scores was collated across items. Conclusions: This is the first systematic multi-stakeholder consultation generating a unique repository of perspectives on pivotal aspects of DM trial design including those of PwP and CP. The panel endorsed outcomes that holistically measure PD and the importance of inclusive trials with hybrid delivery models. Areas of disagreement will inform mitigating strategies of researchers to ensure successful delivery of future trials.

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Section: Discussionmentioning

confidence: 99%

An International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson’s Disease Trials

Zeissler,

McFarthing,

Raphael

et al. 2023

JPD

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“…A remote continuous passive measure of resting tremor in PD is available using inertial measurement units (IMUs) and/or accelerometers embedded in commercial smartwatches, which are usually worn on the more affected wrist [19][20][21][22][23][24][25]. Either tremor acceleration or the mean daily time spent with tremor was correlated with certain aspects of the MDS-UPDRS III tremor sub-scores.…”

Section: Complimentary Technologiesmentioning

confidence: 99%

The digital signature of emergent tremor in Parkinson's disease

Bronte-Stewart,

Gala,

Wilkins

et al. 2023

Preprint

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Background Emergent tremor in Parkinson’s disease (PD) can occur during sustained postures or movement that is different from action tremor. Tremor can contaminate the clinical rating of bradykinesia during finger tapping. Currently, there is no reliable way of isolating emergent tremor and measuring the cardinal motor symptoms based on voluntary movements only. Objective Investigate whether emergent tremor during repetitive alternating finger tapping (RAFT) on a quantitative digitography (QDG) device can be reliably identified and distinguished from voluntary tapping. Methods Ninety-six individuals with PD and forty-two healthy controls performed a thirty-second QDG-RAFT task and the Movement Disorders Society – Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III). Visual identification of tremor during QDG-RAFT was labelled by an experienced movement disorders specialist. Two methods of identifying tremor were investigated: 1) physiologically-informed temporal thresholds 2) XGBoost model using temporal and amplitude features of tapping. Results The XGBoost model showed high accuracy for identifying tremor (area under the precision-recall curve of 0.981) and outperformed temporal-based thresholds. Percent time duration of classifier-identified tremor showed significant correlations with MDS-UPDRS III tremor subscores (r = 0.50, P < 0.0001). There was a significant change in QDG metrics for bradykinesia, rigidity and arrhythmicity after tremor strikes were excluded (p < 0.01). Conclusions Emergent tremor during QDG-RAFT has a unique digital signature and the duration of tremor correlated with the MDS-UPDRS III tremor items. When involuntary tremor strikes were excluded, the QDG metrics of bradykinesia and rigidity were significantly worse, demonstrating the importance of distinguishing tremor from voluntary movement when rating bradykinesia.

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“…This manuscript presents results from Aim 1. All individuals with early PD who completed their final visit of the WATCH-PD parent study [13] within 6 months were eligible to participate (N = 54). Main inclusion criteria for the parent study were: 1) diagnosed PD duration ≤ 2 years; 2) Modified Hoehn & Yahr stage ≤ 2; and 3) not taking any PD medications.…”

Section: Setting Samplementioning

confidence: 99%

Relative Meaningfulness and Impacts of Symptoms in People with Early-Stage Parkinson’s Disease

Mammen,

Speck,

Stebbins

et al. 2023

JPD

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Background: Patient perspectives on meaningful symptoms and impacts in early Parkinson’s disease (PD) are lacking and are urgently needed to clarify priority areas for monitoring, management, and new therapies. Objective: To examine experiences of people with early-stage PD, systematically describe meaningful symptoms and impacts, and determine which are most bothersome or important. Methods: Forty adults with early PD who participated in a study evaluating smartwatch and smartphone digital measures (WATCH-PD study) completed online interviews with symptom mapping to hierarchically delineate symptoms and impacts of disease from “Most bothersome” to “Not present,” and to identify which of these were viewed as most important and why. Individual symptom maps were coded for types, frequencies, and bothersomeness of symptoms and their impacts, with thematic analysis of narratives to explore perceptions. Results: The three most bothersome and important symptoms were tremor, fine motor difficulties, and slow movements. Symptoms had the greatest impact on sleep, job functioning, exercise, communication, relationships, and self-concept— commonly expressed as a sense of being limited by PD. Thematically, most bothersome symptoms were those that were personally limiting with broadest negative impact on well-being and activities. However, symptoms could be important to patients even when not present or limiting (e.g., speech, cognition). Conclusion: Meaningful symptoms of early PD can include symptoms that are present or anticipated future symptoms that are important to the individual. Systematic assessment of meaningful symptoms should aim to assess the extent to which symptoms are personally important, present, bothersome, and limiting

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A Multicenter Study Using a Smartwatch, Smartphone, and Wearable Sensors to Assess Early Parkinson’s Disease: Baseline Results of the WATCH-PD Study

Cited by 4 publications

References 52 publications

An International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson’s Disease Trials

An International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson’s Disease Trials

The digital signature of emergent tremor in Parkinson's disease

Relative Meaningfulness and Impacts of Symptoms in People with Early-Stage Parkinson’s Disease

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