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NCT Number: NCT07787299

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Facility, Western General Hospital, NHS Lothian

Edinburgh, EH4 2XU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Device exposure: Wearable inertial sensor monitoring

Device

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.

Primary outcomes

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

    Time frame: 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.

  2. Completeness of paired wearable and clinical assessment data

    Time frame: 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.

  3. Participant-rated device comfort and usability score

    Time frame: 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.

Secondary outcomes

  1. Completeness of paired home wearable and diary data

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Bernassau

CONTACT

[email protected]

+44 131 451 3358

Gordon Duncan

CONTACT

[email protected]

+44 131 537 3804

Sponsors and collaborators

Lead sponsor

Heriot-Watt University

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Acronym: PD-WATCH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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