Here's an analysis of digital biomarkers for non-motor symptoms in Parkinson's disease (PD), focusing on their potential for use in clinical trials and daily practice.

Digital Biomarkers for Non-Motor Symptoms in Parkinson's Disease

Overview of Digital Biomarkers

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The use of digital biomarkers is rapidly evolving, particularly for assessing motor features of PD. However, the non-motor domain lags behind, despite the substantial impact of non-motor symptoms on the quality of life for individuals with PD [1]. These non-motor symptoms often precede motor symptoms, making them potentially more sensitive as progression biomarkers in disease-modifying trials [1].

Several digital biomarkers show high potential for measuring non-motor symptoms in PD.

Promising Digital Biomarkers

Digital biomarkers offer a more objective, convenient, and potentially more sensitive alternative to traditional episodic in-clinic assessments of disease progression [1]. The Food and Drug Administration (FDA) guidelines emphasize the importance of patient-focused digital health and drug testing, further highlighting the need for these biomarkers [1].

Digital biomarkers with high potential but with a limited current developmental stage include:

Opportunities for Digital Biomarkers

• Sleep-related symptoms are the most promising for prodromal PD. Digital biomarkers for REM sleep behavior disorder and excessive daytime sleepiness have been validated in prodromal cohorts [1]. Accelerometry-based sleep characteristics, such as decreased sleep efficiency and turn velocity, have been validated in multiple PD cohorts and correlate well with polysomnography [1].
• Heart rate variability is in the highest developmental stage of all symptoms. Studies indicate that heart rate variability is already disturbed in people with REM sleep behavior disorder, reliably distinguishes PD from non-PD, and is cross-sectionally associated with disease severity [1].

Feasibility and Challenges

• Neuropsychiatric features
• Cognitive function
• Constipation
• Orthostatic hypotension [1]

Recommendations

Studies have investigated the feasibility of deploying digital biomarkers in PD, with short durations of follow-up. Compliance is generally good with a seamless-fit design, comfortable wear, and either a completely unobtrusive and passive design or a clear added benefit to the participant’s daily life [1]. However, challenges remain, such as limited battery capacity and the need for a clear added benefit to the participant’s daily life [1].

Actionable Steps

• Continued development, longitudinal validation, and feasibility assessment of digital markers for sleep, REM sleep behavior disorder, and excessive daytime sleepiness in real-world situations could be helpful to monitor disease progression in prodromal disease-modifying trials [1].
• Future trials that recruit a prodromal or manifest PD population could consider including heart rate variability as an exploratory digital progression outcome [1].
• For markers of autonomic dysfunction, many proposed sensors were poorly integrated for use in PD trials. For example, for hyperhidrosis monitoring, a combination of an accurate patch, remote synchronization, and longer measurement duration possibilities is necessary for passive monitoring opportunities [1].

Discuss biomarker testing with your doctor and track sleep, movement, and cognition regularly.

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