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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05956834
Recruitment Status : Recruiting
First Posted : July 21, 2023
Last Update Posted : September 7, 2023
Sponsor:
Collaborators:
Johns Hopkins University
BioSensics
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Study Description
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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.


Condition or disease Intervention/treatment
PSP CBD Progressive Supranuclear Palsy FTD Corticobasal Degeneration Frontotemporal Dementia Frontotemporal Lobar Degeneration Device: PAMSys Device: LEGSys

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
Actual Study Start Date : July 28, 2023
Estimated Primary Completion Date : July 30, 2025
Estimated Study Completion Date : December 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: PAMSys
    Wearable accelerometer and gyroscope for measuring movement
  • Device: LEGSys
    Wearable accelerometer and gyroscope for measuring movement

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956834


Contacts
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Contact: Mansi Sharma, BS 6176432400 msharma13@mgh.harvard.edu
Contact: Anne-Marie A Wills, MD MPH 16177265532 awills@mgh.harvard.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21093
Contact: AJ Hall    410-616-2813    ahall52@jhmi.edu   
Principal Investigator: Alex Pantelyat, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mansi Sharma    617-643-2400    msharma13@mgh.harvard.edu   
Principal Investigator: Anne-Marie A Wills, MD MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Johns Hopkins University
BioSensics
More Information
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Responsible Party: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05956834    
Other Study ID Numbers: IRB00341607
First Posted: July 21, 2023    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be available upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 12 months after completion of the study and for 24 months.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Supranuclear Palsy, Progressive
Frontotemporal Lobar Degeneration
Corticobasal Degeneration
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
 Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Basal Ganglia Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Eye Diseases