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NCT Number: NCT05956834

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

PSP Basal Ganglia Diseases Brain Diseases CBD Central Nervous System Diseases Corticobasal Degeneration Cranial Nerve Diseases Dementia Eye Diseases FTD Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Progressive Supranuclear Palsy Proteostasis Deficiencies Signs and Symptoms Supranuclear Palsy, Progressive TDP-43 Proteinopathies Tauopathies

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins School of Medicine, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAMSys

Device

Wearable accelerometer and gyroscope for measuring movement

LEGSys

Device

Wearable accelerometer and gyroscope for measuring movement

Primary outcomes

  1. Feasibility

    Time frame: 12 months

    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).

Secondary outcomes

  1. PSPRS

    Time frame: 12 months

    The Progressive Supranuclear Palsy Rating Scale will be administered 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.

  2. Cortical Basal ganglia Functional Scale (CBFS)

    Time frame: 12 months

    The Cortical Basal ganglia Functional Scale (CBFS) will be performed every 3 months. The CBFS is a 31 item scale, with a total of 124 possible points, where a lower score is less affected.

  3. PSP Quality of Life scale (PSP QoL)

    Time frame: 12 months

    The PSP Quality of Life scale will be performed every 3 months. The PSP-QoL is a 45 item scale, with a possible scale of 0-100 with lower scores less affected.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • BioSensics
  • Johns Hopkins University

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 21, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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