Clinical trial NCT05956834: A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
Official title: A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PSP
CBD
Progressive Supranuclear Palsy
FTD
Corticobasal Degeneration
Frontotemporal Dementia
Frontotemporal Lobar Degeneration
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: BioSensics
First posted: 2023-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Feasibility
timeFrame: 12 months
Secondary outcomes:
measure: PSPRS
timeFrame: 12 months
measure: Cortical Basal ganglia Functional Scale (CBFS)
timeFrame: 12 months
measure: PSP Quality of Life scale (PSP QoL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: