A Wearable Sensor Platform for Remote Monitoring of Individuals on the Frontotemporal Dementia Spectrum (ReMoTe)
5 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
60
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Maryland
-
Lutherville, Maryland, Verenigde Staten, 21093
- Johns Hopkins University School of Medicine
-
Contact:
- Claudia Waddell
- Telefoonnummer: 410-502-3290
- E-mail: cwaddel4@jh.edu
-
Hoofdonderzoeker:
- Alexander Pantelyat, MD
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
-
Contact:
- Jesse Wang
- Telefoonnummer: 617-643-2400
- E-mail: mghpsp@partners.org
-
Hoofdonderzoeker:
- Anne-Marie Wills, MD,MPH
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Frontotemporal Lobar Degeneration (FTLD)
60 patients who have a clinical diagnosis of possible or probable FTLD syndrome phenotype.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physical Activity Monitoring
Tijdsspanne: 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
Tijdsspanne: 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.
|
24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Zarit Burden Interview (ZBI-22)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Digital Speech Assessment
Tijdsspanne: 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
Tijdsspanne: 24 months
|
Using a study tablet, participants will perform a series of digital cognitive assessments.
|
24 months
|
|
Digital Fine Motor Control Assessment
Tijdsspanne: 24 months
|
Using a study tablet, participants will perform a series of tapping tests.
|
24 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
15 augustus 2030
Studie voltooiing (Geschat)
15 december 2030
Studieregistratiedata
Eerst ingediend
29 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
5 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Metabole ziekten
- Neurocognitieve stoornissen
- Dementie
- Tauopathieën
- Neurodegeneratieve ziekten
- TDP-43 Proteïnopathieën
- Proteostase-tekortkomingen
- Voedings- en stofwisselingsziekten
- Corticobasale degeneratie
- Frontotemporale dementie
- Frontotemporale lobaire degeneratie
Andere studie-ID-nummers
- ReMoTe Study
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .