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

26 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Dispositivo: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Wearable sensor data completeness for tremor and upper-limb movement analysis
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Completeness of paired home wearable and diary data
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Heriot-Watt University

Collaboratori

NHS Lothian

Investigatori

  • Cattedra di studio: Anne Bernassau, Heriot-Watt University
  • Investigatore principale: Gordon Duncan, NHS Lothian

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

14 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 agosto 2026

Primo Inserito (Effettivo)

26 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26/NS/0032
  • 361292 (Altro identificatore: Integrated Research Application System (IRAS))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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