A Wearable Sensor Platform for Remote Monitoring of Individuals on the Frontotemporal Dementia Spectrum

NCT07569367 | Not Yet Recruiting

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

Brief Summary

The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with FTLD syndromes.Researchers at BioSensics, Johns Hopkins School of Medicine, and Massachusetts General Hospital will use wearable sensors, computerized speech, psychomotor, and cognitive assessments to create outcome measures and digital biomarkers for FTLD syndromes. Researchers will deploy this digital health solution to monitor 60 patients with FTLD syndromes for 24 months with study visits every 6 months

Conditions

Frontotemporal Lobar Degeneration (FTLD); Frontotemporal Dementia (FTD); Corticobasal Syndrome(CBS); Corticobasal Degeneration

Keywords

digital health; wearable sensors; frontotemportal lobar degeneration

Outcome Measures

Primary Outcomes (2)

• Physical Activity Monitoring

  Following each clinical visit, participants will be asked to wear a PAMSys pendant sensor and two PAMSys ULM wrist sensors for 14 days at home. The average daily number of steps will be measured using the PAMSys pendant.

  24 months

• Hand Function Monitoring

  Following each clinical visit, participants will be asked to wear two PAMSys ULM wrist sensors for 14 days at home. Average daily number of hand goal-directed movements will be measured using the PAMSys ULM wrist sensors.

  24 months

Secondary Outcomes (4)

• Zarit Burden Interview (ZBI-22)

  24 months

• Montreal Cognitive Assessment (MoCA)

  24 months

• Cortical Basal Ganglia Functional Scale (CBFS)

  24 months

• Progressive Supranuclear Palsy Rating Scale (PSPRS)

  24 months

Other Outcomes (3)

• Digital Speech Assessment

  24 months

• Digital Cognitive Assessments

  24 months

• Digital Fine Motor Control Assessment

  24 months

Study Arms (1)

Frontotemporal Lobar Degeneration (FTLD)

60 patients who have a clinical diagnosis of possible or probable FTLD syndrome phenotype.

Eligibility Criteria

• Age: 40 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 FTLD syndrome population. There are no restrictions based on race or ethnic origin. This study will enroll both male and female participants aged 40 years or older with a clinical diagnosis of possible or probable FTLD syndrome phenotype.

You may qualify if:

• Male and female participants aged 40 years or older with a clinical diagnosis of possible or probable FTLD syndrome phenotype.
• Participants must be fluent in reading and speaking English and must be capable of providing informed consent based on the principal investigator's judgment.

You may not qualify if:

• Any neurological, medical, or psychiatric condition that would preclude or confound participation in study activities based on the investigator's judgment.
• Individuals who have a history of frequent falls defined as more than 5 falls per month.

Sponsors & Collaborators

• BioSensics: lead
• Johns Hopkins University: collaborator
• Massachusetts General Hospital: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

Johns Hopkins University School of Medicine

Lutherville, Maryland, 21093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Frontotemporal Lobar Degeneration; Frontotemporal Dementia; Corticobasal Degeneration

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (2)