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

NCT05956834 | Active Not Recruiting

• 1 other identifier: IRB00341607
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Feasibility will be defined by the number of participants who complete the 12 month study and who wear their PAMSys pendant sensors at least 16 hours/day for at least 75% of the designated sensor days (7 days per month).

  12 months

Secondary Outcomes (3)

• PSPRS

  12 months

• Cortical Basal ganglia Functional Scale (CBFS)

  12 months

• PSP Quality of Life scale (PSP QoL)

  12 months

Interventions

PAMSys DEVICE

Wearable accelerometer and gyroscope for measuring movement

LEGSys DEVICE

Wearable accelerometer and gyroscope for measuring movement

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study intends to enroll a diverse population of individuals representative of the general PSP population. There are no restrictions based upon race or ethnic origin. This study will recruit both male and female participants aged 40 years or older with a clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: collaborator
• Massachusetts General Hospital: lead
• BioSensics: collaborator

Study Sites (2)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Corticobasal Degeneration; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after completion of the study and for 24 months.

Locations

US (2)