Remote Monitoring in Progressive Supranuclear Palsy (PSP)

Study Overview
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Brief Summary
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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
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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, 40-50 individuals with possible or probable PSP will be enrolled at 4-5 sites in the U.S. and followed for one year. During the monitoring period (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). 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).

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

Conditions
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Progressive Supranuclear Palsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria[12]. Male or female, aged 18 to 89 years, inclusive. Fluent in reading and speaking English. Capable of providing informed consent based on the investigator's judgment. Able to comply with the protocol based on the investigator's judgment. Able to walk 10 feet unassisted. With access to a caregiver who is able to assist with all study-related procedures. Exclusion Criteria: Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment. A history of frequent falls defined as more than 5 falls/month or requirement of a walker to ambulate safely.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary feasibility outcome | Compliance will be calculated as the number of participants who wear their PAMSys pendant sensors at least 16 hours/day for at least 180 days and complete at least 80% of their scheduled monthly sensor and tablet derived motor, speech, and cognitive assessments through their 6 month visit. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) | The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors | 12 months | 
| PSPRS | The Progressive Supranuclear Palsy Rating Scale will be administered remotely or in-person every 3 months. The PSPRS is a 28 item scale with a total score of 0-100 where lower scores are less affected. | 12 months | 
| MoCA | The Montreal Cognitive Assessment and other cognitive tests will be performed remotely every 3 months. The MoCA is has a total of 30 points and greater than 26 is considered normal. | 12 months | 
| Cortical Basal ganglia Functional Scale (CBFS) | The Cortical Basal ganglia Functional Scale (CBFS) will be performed every 3 months remotely. The CBFS is a 31 item scale, with a total of 124 possible points, where a lower score is less affected. | 12 months | 
| PSP-QoL | The PSP Quality of Life scale will be performed every 3 months remotely. The PSP-QoL is a 45 item scale, with a possible scale of 0-100 with lower scores less affected. | 12 months |