Objectively Monitoring Amyotrophic Lateral Sclerosis Patient Symptoms During Clinical Trials With Sensors:...

Area of Science:

• Biomedical Engineering
• Neurology
• Digital Health

Background:

• Objective symptom monitoring in Amyotrophic Lateral Sclerosis (ALS) is crucial for assessing real-world functional capacity.
• Home-based data collection offers valuable insights for clinical trials and understanding disease impact.

Purpose of the Study:

• To evaluate the feasibility of a novel digital platform for remote data collection in 25 ALS patients.
• To assess the collection of physical activity, heart rate variability (HRV), and digital speech characteristics over 48 weeks.
• To explore the impact of remote monitoring devices on patients' daily lives and their tolerability.

Main Methods:

• An observational, noncontrolled, non-drug study involving 25 ALS patients.
• Patients attended quarterly clinical visits for sensor tasks and conventional monitoring.
• Home monitoring involved wearing a sensor for approximately 3 days monthly.

Main Results:

• Digital speech data captured in-clinic met expectations.
• Home monitoring yielded less physical activity data than anticipated (65% of protocol time points).
• Lower quality HRV data and mild skin irritation (6/25 patients) were observed; no serious adverse events occurred.

Conclusions:

• The digital platform is feasible for measuring home-based physical activity in ALS patients.
• Despite lower data quantity, physical activity monitoring can support novel endpoint investigations.
• Future research leveraging objective monitoring and technology can identify digital biomarkers for ALS progression.