A Wearable Sensor Platform for Remote Monitoring of Individuals on the Frontotemporal Dementia Spectrum
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD), Corticobasal Degeneration, Corticobasal Syndrome (CBS). Базовые параметры: от 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Physical Activity Monitoring [Срок оценки: 24 months]
- Hand Function Monitoring [Срок оценки: 24 months]
Вторичные конечные точки (4)
- Zarit Burden Interview (ZBI-22) [Срок оценки: 24 months]
- Montreal Cognitive Assessment (MoCA) [Срок оценки: 24 months]
- Cortical Basal Ganglia Functional Scale (CBFS) [Срок оценки: 24 months]
- Progressive Supranuclear Palsy Rating Scale (PSPRS) [Срок оценки: 24 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 2 центра
- Johns Hopkins University School of Medicine — Lutherville
- Massachusetts General Hospital — Boston
Идентификаторы
NCT: NCT07569367 · ReMoTe Study