Wearable for Assessing Tremor and Continuous Health in Parkinson's Disease and Essential Tremor (PD-WATCH)
26. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
60
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Gordon Duncan
- Telefonnummer: +44 131 537 3804
- E-Mail: gordon.duncan2@nhs.scot
Studieren Sie die Kontaktsicherung
- Name: Anne Bernassau
- Telefonnummer: +44 131 451 3358
- E-Mail: a.bernassau@hw.ac.uk
Studienorte
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Edinburgh
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Edinburgh, Edinburgh, Vereinigtes Königreich, EH4 2XU
- Clinical Research Facility, Western General Hospital, NHS Lothian
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- Aged 18 years or older.
- Clinical diagnosis of idiopathic Parkinson's disease (Hoehn and Yahr stage I-III) or essential tremor.
- Motor or tremor symptoms confirmed on clinical assessment.
- Able to walk at least 4 metres independently, with or without a walking aid.
- Able to provide written informed consent and comply with study procedures.
- Willing and able to wear the study sensors in clinic and, where applicable, at home.
- Able to understand study information and complete study materials in English.
Exclusion Criteria:
- A recent major cardiovascular or cerebrovascular event, or another unstable condition that would make participation unsafe.
- An uncontrolled psychiatric disorder, ongoing substance misuse, active systemic cancer treatment, or another serious illness likely to interfere with participation.
- Pregnancy at enrolment.
- Active skin disease or known allergy to adhesive plaster at anticipated sensor sites.
- Dementia with Lewy Bodies, atypical, vascular, or drug-induced parkinsonism.
- Previous invasive neuromodulation or neurosurgery for a movement disorder, including deep brain stimulation.
- Current or recent participation in another interventional study that could affect safety or study outcomes.
- In the investigator's opinion, unable to complete the study procedures safely.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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.
|
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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Wearable sensor data completeness for tremor and upper-limb movement analysis
Zeitfenster: 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.
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Day 1 through completion of home monitoring, up to 22 days.
|
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Completeness of paired wearable and clinical assessment data
Zeitfenster: 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
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Completeness of paired home wearable and diary data
Zeitfenster: 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.
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Home monitoring period, up to 21 days.
|
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Completeness of paired pre-dose and post-dose wearable data
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Anne Bernassau, Heriot-Watt University
- Hauptermittler: Gordon Duncan, NHS Lothian
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
14. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. August 2026
Zuerst gepostet (Tatsächlich)
26. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
31. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Synucleinopathien
- Neurologische Manifestationen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neurodegenerative Krankheiten
- Bewegungsstörungen
- Parkinsonsche Störungen
- Erkrankungen der Basalganglien
- Dyskinesien
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Parkinson Krankheit
- Tremor
Andere Studien-ID-Nummern
- 26/NS/0032
- 361292 (Andere Kennung: Integrated Research Application System (IRAS))
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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