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临床试验/NCT07569367
NCT07569367尚未招募不适用

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

BioSensics2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Physical Activity Monitoring

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Frontotemporal Lobar Degeneration (FTLD)

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

结局指标

主要结局

Physical Activity Monitoring

时间窗: 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.

Hand Function Monitoring

时间窗: 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.

次要结局

  • 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)

研究者

发起方
BioSensics
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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