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

NCT07787299 | Not Yet Recruiting

• 2 other identifiers: 26/NS/0032361292
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Completeness of paired home wearable and diary data

  Home monitoring period, up to 21 days.

• Completeness of paired pre-dose and post-dose wearable data

  Day 1.

Study Arms (2)

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

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.

Essential Tremor cohort (n=20); Parkinson's disease cohort (n=40)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heriot-Watt University: lead
• NHS Lothian: collaborator

Study Sites (1)

Clinical Research Facility, Western General Hospital, NHS Lothian

Edinburgh, Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Bernassau

  Heriot-Watt University

  STUDY CHAIR

• Gordon Duncan

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon Duncan

CONTACT

+44 131 537 3804; gordon.duncan2@nhs.scot

Anne Bernassau

CONTACT

+44 131 451 3358; a.bernassau@hw.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Engineering

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)