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

Progressive Supranuclear Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956834
• Other study ID #: IRB00341607
• Status: Recruiting
• Start date: July 28, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Mansi Sharma, BS
• Phone: 6176432400
• Email: msharma13[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2026
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• CBD
• Corticobasal Degeneration
• Frontotemporal Dementia
• Frontotemporal Lobar Degeneration
• FTD
• Pick Disease of the Brain
• Progressive Supranuclear Palsy
• PSP
• Supranuclear Palsy, Progressive

Intervention

Device:
• PAMSys
Wearable accelerometer and gyroscope for measuring movement
• LEGSys
Wearable accelerometer and gyroscope for measuring movement

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	BioSensics LLC, Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PSPRS	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.	12 months
Secondary	Cortical Basal ganglia Functional Scale (CBFS)	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.	12 months
Secondary	PSP Quality of Life scale (PSP QoL)	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.	12 months