Brief Title
Remote Monitoring in Progressive Supranuclear Palsy (PSP)
Official Title
Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia
Brief 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, 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).
Study Type
Observational
Primary Outcome
Primary feasibility outcome
Secondary Outcome
Timed Up and Go (TUG)
Condition
Progressive Supranuclear Palsy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
50
Start Date
March 2021
Completion Date
December 2023
Primary Completion Date
June 2023
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 89 Years
Accepts Healthy Volunteers
No
Contacts
Anne-Marie A Wills, MD MPH, 617-643-2400, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04753320
Organization ID
Not yet available
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Collaborators
Johns Hopkins University
Study Sponsor
Anne-Marie A Wills, MD MPH, Principal Investigator, Massachusetts General Hospital
Verification Date
February 2021