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Wearable for Assessing Tremor and Continuous Health in Parkinson's Disease and Essential Tremor (PD-WATCH)

26. august 2026 oppdatert av: Anne Bernassau, Heriot-Watt University

Wearable for Assessing Tremor and Continuous Health in Parkinson's and Essential Tremor Diseases

This prospective observational study will examine tremor and upper-limb movement in adults with Parkinson's disease or essential tremor using non-invasive wearable sensors. Participants will attend one clinic visit and may then wear sensors at home for 3, 7, or 21 days. Clinic assessments will be scheduled around participants' usual medication times; the study will not change or delay treatment. Sensor data will be analysed offline for research and will not be used to make clinical decisions.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study will recruit up to 60 adults through NHS Lothian: 40 with Parkinson's disease and 20 with essential tremor. During the clinic visit, participants will complete clinical assessments and movement tasks while wearing the PD-WATCH research sensor and comparator wearable sensors. Participants allocated to home monitoring will wear the sensors during usual daily activities and complete brief medication, symptom, and activity logs. The study will describe wearable-derived movement features, explore their relationships with clinical assessments and medication timing, and assess the feasibility and acceptability of wearable monitoring. The study is exploratory and is not designed to evaluate diagnostic accuracy, treatment effects, or device performance.

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.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Storbritannia
    • Edinburgh
      • Edinburgh, Edinburgh, Storbritannia, EH4 2XU
        • Clinical Research Facility, Western General Hospital, NHS Lothian

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

Adults with a clinical diagnosis of idiopathic Parkinson's disease or essential tremor receiving care through NHS Lothian services. Potential participants will be identified through relevant NHS clinical pathways.

Beskrivelse

Inclusion Criteria:

  1. Aged 18 years or older.
  2. Clinical diagnosis of idiopathic Parkinson's disease (Hoehn and Yahr stage I-III) or essential tremor.
  3. Motor or tremor symptoms confirmed on clinical assessment.
  4. Able to walk at least 4 metres independently, with or without a walking aid.
  5. Able to provide written informed consent and comply with study procedures.
  6. Willing and able to wear the study sensors in clinic and, where applicable, at home.
  7. Able to understand study information and complete study materials in English.

Exclusion Criteria:

  1. A recent major cardiovascular or cerebrovascular event, or another unstable condition that would make participation unsafe.
  2. An uncontrolled psychiatric disorder, ongoing substance misuse, active systemic cancer treatment, or another serious illness likely to interfere with participation.
  3. Pregnancy at enrolment.
  4. Active skin disease or known allergy to adhesive plaster at anticipated sensor sites.
  5. Dementia with Lewy Bodies, atypical, vascular, or drug-induced parkinsonism.
  6. Previous invasive neuromodulation or neurosurgery for a movement disorder, including deep brain stimulation.
  7. Current or recent participation in another interventional study that could affect safety or study outcomes.
  8. In the investigator's opinion, unable to complete the study procedures safely.

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
Intervensjon / Behandling
Parkinson's disease cohort (n=40)
Adults with idiopathic Parkinson's disease who complete clinic-based assessment and wearable monitoring, with home monitoring for 3, 7, or 21 days.
Enhet: Device exposure: Wearable inertial sensor monitoring
PD-WATCH and comparator wearable sensors are used only to collect research data. Both cohorts continue their usual medication and clinical care; no treatment is assigned or changed by the study.
Essential Tremor cohort (n=20)
Adults with essential tremor who complete clinic-based assessment and wearable monitoring, with home monitoring for 3, 7, or 21 days.
Enhet: Device exposure: Wearable inertial sensor monitoring
PD-WATCH and comparator wearable sensors are used only to collect research data. Both cohorts continue their usual medication and clinical care; no treatment is assigned or changed by the study.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wearable sensor data completeness for tremor and upper-limb movement analysis
Tidsramme: Day 1 through completion of home monitoring, up to 22 days.
Percentage of participants with sufficient valid wearable sensor data to extract predefined tremor and upper-limb movement features for descriptive analysis. This will be calculated as the number of participants with usable sensor recordings divided by the number of participants who started the relevant clinic or home-monitoring assessment, multiplied by 100.
Day 1 through completion of home monitoring, up to 22 days.
Completeness of paired wearable and clinical assessment data
Tidsramme: Day 1.
Percentage of participants with usable paired wearable sensor recordings and clinician-rated motor assessment data available for exploratory correlation analysis. This will be calculated as the number of participants with both valid wearable data and relevant clinical assessment data divided by the number of participants completing the clinic visit, multiplied by 100.
Day 1.
Participant-rated device comfort and usability score
Tidsramme: Day 1 and at completion of home monitoring, up to 22 days.
Mean participant-rated device comfort and usability score, calculated from study questionnaire items scored from 1 to 5. A score of 1 indicates "not satisfied" and 5 indicates "very satisfied". Higher scores indicate better comfort, usability, perceived safety, and acceptability. Scores will be reported separately for Day 1 and for completion of home monitoring, where available.
Day 1 and at completion of home monitoring, up to 22 days.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Completeness of paired home wearable and diary data
Tidsramme: Home monitoring period, up to 21 days.
Percentage of participants with sufficient paired home wearable sensor data and participant diary data available for time-aligned descriptive analysis. This will be calculated as the number of participants with usable wearable recordings and corresponding medication, symptom, or activity diary entries divided by the number of participants who started home monitoring, multiplied by 100.
Home monitoring period, up to 21 days.
Completeness of paired pre-dose and post-dose wearable data
Tidsramme: Day 1.
Percentage of participants with usable wearable sensor recordings at both pre-dose and post-dose clinic assessments available for within-participant descriptive comparison. This will be calculated as the number of participants with valid wearable data at both clinic timepoints divided by the number of participants completing both clinic assessments, multiplied by 100.
Day 1.

Samarbeidspartnere og etterforskere

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

Sponsor

Heriot-Watt University

Samarbeidspartnere

NHS Lothian

Etterforskere

  • Studiestol: Anne Bernassau, Heriot-Watt University
  • Hovedetterforsker: Gordon Duncan, NHS Lothian

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. september 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

14. august 2026

Først innsendt som oppfylte QC-kriteriene

21. august 2026

Først lagt ut (Faktiske)

26. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26/NS/0032
  • 361292 (Annen identifikator: Integrated Research Application System (IRAS))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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