Wearable for Assessing Tremor and Continuous Health in Parkinson's Disease and Essential Tremor (PD-WATCH)
Wearable for Assessing Tremor and Continuous Health in Parkinson's and Essential Tremor Diseases
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Gordon Duncan
- Número de teléfono: +44 131 537 3804
- Correo electrónico: gordon.duncan2@nhs.scot
Copia de seguridad de contactos de estudio
- Nombre: Anne Bernassau
- Número de teléfono: +44 131 451 3358
- Correo electrónico: a.bernassau@hw.ac.uk
Ubicaciones de estudio
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Edinburgh
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Edinburgh, Edinburgh, Reino Unido, EH4 2XU
- Clinical Research Facility, Western General Hospital, NHS Lothian
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Wearable sensor data completeness for tremor and upper-limb movement analysis
Periodo de tiempo: Day 1 through completion of home monitoring, up to 22 days.
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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
Periodo de tiempo: Day 1.
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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.
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Day 1.
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Participant-rated device comfort and usability score
Periodo de tiempo: Day 1 and at completion of home monitoring, up to 22 days.
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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.
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Day 1 and at completion of home monitoring, up to 22 days.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Completeness of paired home wearable and diary data
Periodo de tiempo: Home monitoring period, up to 21 days.
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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
Periodo de tiempo: Day 1.
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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.
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Day 1.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Silla de estudio: Anne Bernassau, Heriot-Watt University
- Investigador principal: Gordon Duncan, NHS Lothian
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Discinesias
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedad de Parkinson
- Temblor
Otros números de identificación del estudio
Otros números de identificación del estudio
- 26/NS/0032
- 361292 (Otro identificador: Integrated Research Application System (IRAS))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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