Remote Monitoring in Progressive Supranuclear Palsy (PSP)

Phase

N/A

Condition

Progressive Supranuclear Palsy

Multiple System Atrophy

Treatment

N/A

Clinical Study ID

NCT04753320

Not yet available

Ages 18-89
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDScriteria, clinical diagnosis of at least probable PD as defined by the 2015 MDScriteria, or clinical diagnosis of at least probable MSA as defined by the 2022 MDScriteria, 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

Exclusion Criteria:

Any neurological, medical, or psychiatric condition that would precludeparticipation in study activities based on the investigator's judgment.
A history of frequent falls defined as more than 5 falls/month or requirement of awalker to ambulate safely.

Study Design

May 05, 2021

December 31, 2026

Study 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).

Connect with a study center

Johns Hopkins
Baltimore, Maryland 21093
United States
Site Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.