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

5. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Lutherville, Maryland, Forente stater, 21093
        • Johns Hopkins University School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alexander Pantelyat, MD
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Anne-Marie Wills, MD,MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Frontotemporal Lobar Degeneration (FTLD)
60 patients who have a clinical diagnosis of possible or probable FTLD syndrome phenotype.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Activity Monitoring
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Zarit Burden Interview (ZBI-22)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Digital Speech Assessment
Tidsramme: 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
Tidsramme: 24 months
Using a study tablet, participants will perform a series of digital cognitive assessments.
24 months
Digital Fine Motor Control Assessment
Tidsramme: 24 months
Using a study tablet, participants will perform a series of tapping tests.
24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

BioSensics

Samarbeidspartnere

Johns Hopkins University
Massachusetts General Hospital
United States Department of Defense

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

15. august 2030

Studiet fullført (Antatt)

15. desember 2030

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ReMoTe Study

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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