A Wearable Sensor Platform for Remote Monitoring of Individuals on the Frontotemporal Dementia Spectrum (ReMoTe)
2026년 5월 5일 업데이트: BioSensics
The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with frontotemporal lobar degeneration (FTLD) syndromes.
Researchers at BioSensics, Johns Hopkins University 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
Frontotemporal degeneration (FTD) spans the spectrum of rare neurodegenerative disorders affecting movement, behavior, and cognitive function.
FTD represents a group of disorders including progressive supranuclear palsy (PSP - a severe and rapidly progressive FTD disorder estimated to affect at least 20,000 Americans), frontotemporal dementia (FTD, the second most common cause of early-onset (<65) dementia), primary progressive aphasia (PPA), semantic dementia (SD), and corticobasal syndrome (CBS).
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.
Sixty patients with FTLD syndromes will be recruited from Johns Hopkins University School of Medicine and Massachusetts General Hospital to participate in this 24-month study with visits every 6 months.
The investigators aim to assess the correlation between outcomes as measured by the PAMSys pendant and PAMSys ULM wrist monitoring sensors, and clinical/functional assessments used for FTLD syndromes (behavioral variant frontotemporal dementia (bvFTD), non-fluent primary progressive aphasia (nfPPA), SD, and CBS), including the FTD Rating Scale (FTDRS), Cortical Basal Ganglia Functional Scale (CBFS), PSP Rating Scale (PSPRS), Frontotemporal lobar degeneration - Clinical Dementia Rating (FTLD-CDR) , modified Interpersonal Reactivity Index (mIRI Perspective Taking and Empathic Concern subscales summed to obtain a total Empathy score), the Pyramids and Palm Trees test (PPT), the Bedside Western Aphasia Battery-Revised (BWAB-R), phonemic fluency, and category fluency, in individuals with different stages of FTLD disease severity.
The results will be used to develop and validate monitoring symptoms and function in FTLD syndromes.
In an exploratory aim, the caregiver burden (Zarit Burden Inventory) and its relationship to patients' empathy levels (mIRI) will be assessed.
The secondary objective of this study is to conduct free-flowing interviews with participants and clinical experts using the Technology Acceptance Model (TAM).
This approach will help us examine perceptions of benefit, technology acceptance, technological anxiety, trust, facilitating conditions, perceived risk, and attitudes towards use from the perspectives of both patients and clinicians.
연구 유형
관찰
등록 (추정된)
60
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Maryland
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Lutherville, Maryland, 미국, 21093
- Johns Hopkins University School of Medicine
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연락하다:
- Claudia Waddell
- 전화번호: 410-502-3290
- 이메일: cwaddel4@jh.edu
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수석 연구원:
- Alexander Pantelyat, MD
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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연락하다:
- Jesse Wang
- 전화번호: 617-643-2400
- 이메일: mghpsp@partners.org
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수석 연구원:
- Anne-Marie Wills, MD,MPH
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
Inclusion Criteria:
- 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.
- Individuals eligible for inclusion must be able to comply with the protocol per the investigator's judgment and 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 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Frontotemporal Lobar Degeneration (FTLD)
60 patients who have a clinical diagnosis of possible or probable FTLD syndrome phenotype.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Activity Monitoring
기간: 24 months
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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.
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24 months
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Hand Function Monitoring
기간: 24 months
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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.
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Zarit Burden Interview (ZBI-22)
기간: 24 months
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The Zarit Burden Interview is completed by a reliable caregiver.
The ZBI scores range from 0-88, where 88 represents a worse outcome.
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24 months
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Montreal Cognitive Assessment (MoCA)
기간: 24 months
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This is a brief global cognitive screening assessment.
Scores range from 0 to 30 where 0 represents a worse outcome.
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24 months
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Cortical Basal Ganglia Functional Scale (CBFS)
기간: 24 months
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The CBFS is a rating scale that evaluates experiences in daily living (EDLs) and consists of 14 questions on Motor EDLs and 17 questions on Non-Motor EDLs, each of which are rated on a Likert 5-point scale rating function from 0 to 4, where 0 = Normal or no problems and 4 = Severe problems.
The questions are for the patient, but should be answered by both the patient and their caregiver together.
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24 months
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Progressive Supranuclear Palsy Rating Scale (PSPRS)
기간: 24 months
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The Progressive Supranuclear Palsy Rating Scale (PSPRS) is a 28-item clinical assessment used to measure the severity and progression of progressive supranuclear palsy (PSP).
Out of the 28 items, 6 are scored on a 3-point scale (0-3) and 22 are scored on a 4-point scale (0-4).
The PSPRS ranges from a score of 0-100 with a higher score representing greater impairment from the disease.
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24 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Digital Speech Assessment
기간: 24 months
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Using a study tablet, participants will perform a series of digital speech assessments.
The collected speech data will be analyzed using BioDigit Speech, an automatic speech analysis software developed by BioSensics.
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24 months
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Digital Cognitive Assessments
기간: 24 months
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Using a study tablet, participants will perform a series of digital cognitive assessments.
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24 months
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Digital Fine Motor Control Assessment
기간: 24 months
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Using a study tablet, participants will perform a series of tapping tests.
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24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2030년 8월 15일
연구 완료 (추정된)
2030년 12월 15일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2026년 4월 1일
추가 정보
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