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Not yet recruitingNCT07787299PD-WATCHUpdated Aug 31, 2026

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

An observational study in PARKINSON DISEASE (Disorder), sponsored by Heriot-Watt University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Heriot-Watt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • PARKINSON DISEASE (Disorder)

Keywords

  • Tremor
  • Upper-limb movement
  • Home monitoring
  • Inertial measurement unit
  • Wearable sensors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Device exposure: Wearable inertial sensor monitoring

  • 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.

    Device: Device exposure: Wearable inertial sensor monitoring

Interventions

  • DeviceDevice 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.

05

What researchers measure

Primary outcomes

  1. Wearable sensor data completeness for tremor and upper-limb movement analysis

    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.

    Time frame: Day 1 through completion of home monitoring, up to 22 days.

  2. Completeness of paired wearable and clinical assessment data

    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.

    Time frame: Day 1.

  3. Participant-rated device comfort and usability score

    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.

    Time frame: Day 1 and at completion of home monitoring, up to 22 days.

Secondary outcomes

  1. Completeness of paired home wearable and diary data

    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.

    Time frame: Home monitoring period, up to 21 days.

  2. Completeness of paired pre-dose and post-dose wearable data

    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.

    Time frame: Day 1.

06

Study locations

1 site
  • Clinical Research Facility, Western General Hospital, NHS Lothian
    Edinburgh, Edinburgh EH4 2XU, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07787299
Lead sponsor
Heriot-Watt University
Collaborators
NHS Lothian
Responsible party
Anne Bernassau (Assistant Professor in Engineering, Heriot-Watt University) — Principal investigator
First posted
Aug 26, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Gordon Duncan
Contact
gordon.duncan2@nhs.scot
+44 131 537 3804
Anne Bernassau
Contact
a.bernassau@hw.ac.uk
+44 131 451 3358
Anne Bernassau
study chair · Heriot-Watt University
Gordon Duncan
principal investigator · NHS Lothian

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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