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

August 26, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 through completion of home monitoring, up to 22 days.
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.
Day 1.
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.
Day 1 and at completion of home monitoring, up to 22 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Home monitoring period, up to 21 days.
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.
Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heriot-Watt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Lothian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anne Bernassau, Heriot-Watt University
  • Principal Investigator: Gordon Duncan, NHS Lothian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26/NS/0032
  • 361292 (Other Identifier: Integrated Research Application System (IRAS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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