A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes

NCT ID: NCT05956834

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2027-12-30

Brief Summary

The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months.

The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.

Detailed Description

The goal of this project is to develop a robust multi-modal platform for remote monitoring of motor symptoms and cognitive function in FTLD syndromes using wearable sensors and mobile health technology to assess speech, motor, and cognitive functions. The solution will be validated in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP individuals with PSP. Enrollment will take place over a period of 24 months, though each participant will only be followed for 12 months for data collection. The participants will consist of adult volunteers from two leading CurePSP Centers of Care located at the Atypical Parkinsonism Center at Johns Hopkins Hospital in Baltimore, MD and Massachusetts General Hospital (MGH) in Boston, MA.

Conditions

PSP; CBD; Progressive Supranuclear Palsy; FTD; Corticobasal Degeneration; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PAMSys

Wearable accelerometer and gyroscope for measuring movement

Intervention Type: DEVICE

LEGSys

Wearable accelerometer and gyroscope for measuring movement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of possible or probable PSP as defined by the 2017 MDS criteria
• Fluent in reading and speaking English and capable of providing informed consent based on the principal investigator's judgement
• Able to walk 10 feet unassisted at the time of initial enrollment
• Must have a caregiver or study partner who is willing and 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 per month, or who require a walker to ambulate safely at baseline will not be eligible to participate in the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

BioSensics

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne-Marie Alexandra Wills, MD

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB00341607

Identifier Type: -

Identifier Source: org_study_id