A Wearable Sensor Platform for Remote Monitoring of Individuals on the Frontotemporal Dementia Spectrum (ReMoTe)
2026年5月5日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
观察性的
注册 (估计的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Maryland
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Lutherville、Maryland、美国、21093
- Johns Hopkins University School Of Medicine
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接触：
- Claudia Waddell
- 电话号码：410-502-3290
- 邮箱：cwaddel4@jh.edu
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首席研究员：
- Alexander Pantelyat, MD
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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接触：
- Jesse Wang
- 电话号码：617-643-2400
- 邮箱：mghpsp@partners.org
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首席研究员：
- Anne-Marie Wills, MD,MPH
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Frontotemporal Lobar Degeneration (FTLD)
60 patients who have a clinical diagnosis of possible or probable FTLD syndrome phenotype.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Activity Monitoring
大体时间：24 months
|
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
大体时间：24 months
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Zarit Burden Interview (ZBI-22)
大体时间：24 months
|
The Zarit Burden Interview is completed by a reliable caregiver.
The ZBI scores range from 0-88, where 88 represents a worse outcome.
|
24 months
|
|
Montreal Cognitive Assessment (MoCA)
大体时间：24 months
|
This is a brief global cognitive screening assessment.
Scores range from 0 to 30 where 0 represents a worse outcome.
|
24 months
|
|
Cortical Basal Ganglia Functional Scale (CBFS)
大体时间：24 months
|
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.
|
24 months
|
|
Progressive Supranuclear Palsy Rating Scale (PSPRS)
大体时间：24 months
|
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.
|
24 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Digital Speech Assessment
大体时间：24 months
|
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.
|
24 months
|
|
Digital Cognitive Assessments
大体时间：24 months
|
Using a study tablet, participants will perform a series of digital cognitive assessments.
|
24 months
|
|
Digital Fine Motor Control Assessment
大体时间：24 months
|
Using a study tablet, participants will perform a series of tapping tests.
|
24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2030年8月15日
研究完成 (估计的)
2030年12月15日
研究注册日期
首次提交
2026年4月29日
首先提交符合 QC 标准的
2026年4月29日
首次发布 (实际的)
2026年5月6日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年4月1日
更多信息
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