Remote Monitoring in Progressive Supranuclear Palsy (PSP)

N/AActive Not RecruitingNCT04753320

Massachusetts General Hospital85 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Progressive Supranuclear Palsy Parkinson Disease MSA - Multiple System Atrophy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria, clinical diagnosis of at least probable PD as defined by the 2015 MDS criteria, or clinical diagnosis of at least probable MSA as defined by the 2022 MDS criteria, or healthy controls. * 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.

Locations (2)

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Timed Up and Go (TUG)

The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

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