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

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: Not yet recruiting
• Conditions: PARKINSON DISEASE (Disorder)
• Intervention / Treatment: Device: Device exposure: Wearable inertial sensor monitoring

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: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Gordon Duncan; Phone Number: +44 131 537 3804; Email: gordon.duncan2@nhs.scot
• Study Contact Backup: Name: Anne Bernassau; Phone Number: +44 131 451 3358; Email: a.bernassau@hw.ac.uk

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Day 1 through completion of home monitoring, up to 22 days.
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.	Day 1.
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.	Day 1 and at completion of home monitoring, up to 22 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Home monitoring period, up to 21 days.
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.	Day 1.

Collaborators and Investigators

• Sponsor: Heriot-Watt University
• Collaborators: NHS Lothian
• Investigators: Study Chair: Anne Bernassau, Heriot-Watt University; Principal Investigator: Gordon Duncan, NHS Lothian

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 14, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Wearable sensors; Tremor; Home monitoring; Inertial measurement unit; Upper-limb movement
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Dyskinesias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Tremor
• Other Study ID 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