NCT04753320

Remote Monitoring in Progressive Supranuclear Palsy (PSP)

Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 85 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, longitudinal, observational study on the use of wearable sensors and digital health technology to measure fall frequency and motor, speech, and cognitive function in patients with PSP over the course of approximately one year. Participants will perform supervised remote assessments monthly and in-person assessments approximately every 6 months.

Detailed description

The primary objective of this study is to determine the feasibility of using wearable sensors and digital health technology to remotely monitor patients with possible or probable PSP. Secondary objectives are to measure PSP progression using sensor-derived motor and tablet-derived speech and cognitive measures. In brief, approximately 85 individuals with possible or probable PSP, probable Parkinson's disease, possible or probable Multiple System Atrophy, and healthy controls, will be enrolled at 4-5 sites in the U.S. and followed for one year. During the monitoring period for PSP and MSA participants (1 year), a wearable pendant sensor (PAMSys, BioSensics) will be used to monitor falls and physical activity (step counts) of all participants during activities of daily living (ADL). Parkinson's and healthy control participants will be seen once at baseline only. On a monthly basis, participants will have televideo conferences with the sites to perform supervised gait and balance tasks while wearing 3 LEGSys (BioSensics) sensors. Using a study-supplied tablet, participants will also perform cognitive tests including fluency, color trails and go-no-go tapping tests. Participants will undergo more extensive testing every 3 months including the PSPRS, MoCA, quality of life questionnaires and functional rating scales which will be performed remotely (virtually). Approximately 6 months participants will undergo an in-person PSPRS (to coincide with their clinic appointments).

Conditions

• Progressive Supranuclear Palsy
• Parkinson Disease
• MSA - Multiple System Atrophy

Timeline

• Start date: 2021-05-05
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2021-02-15
• Last updated: 2025-05-01

Locations

2 sites across 1 country: United States