PARKINSON DISEASE (Disorder)PD-WATCHNCT07787299
Wearable for Assessing Tremor and Continuous Health in Parkinson's Disease and Essential Tremor
An observational study of PARKINSON DISEASE (Disorder), run by Heriot-Watt University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Device exposure: Wearable inertial sensor monitoring
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Facility, Western General Hospital, NHS Lothian
Edinburgh, Edinburgh, EH4 2XU
Gordon Duncan, +44 131 537 3804, gordon.duncan2@nhs.scot
About this study
Official title: 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.
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Device exposure: Wearable inertial sensor monitoring
- Keywords
- Tremor, Upper-limb movement, Home monitoring, Inertial measurement unit, Wearable sensors
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device exposure: Wearable inertial sensor monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Device exposure: Wearable inertial sensor monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 and at completion of home monitoring, up to 22 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heriot-Watt University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Principal investigator, Anne Bernassau, Heriot-Watt University
- Investigators
- Anne Bernassau, Study chair, Heriot-Watt UniversityGordon Duncan, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787299
- Sponsor's protocol ID
- 26/NS/0032
- Other IDs
- 361292
- Acronym
- PD-WATCH
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable for Assessing Tremor and Continuous Health in Parkinson's and Essential Tremor Diseases
- ClinicalTrials.gov ID
- NCT07787299
- Acronym / sponsor ID
- PD-WATCH / 26/NS/0032
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Tremor, Upper-limb movement, Home monitoring, Inertial measurement unit, Wearable sensors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heriot-Watt UniversityUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease cohort (n=40) | – | Device: Device exposure: Wearable inertial sensor monitoringAdults with idiopathic Parkinson's disease who complete clinic-based assessment and wearable monitoring, with home monitoring for 3, 7, or 21 days. |
| Essential Tremor cohort (n=20) | – | Device: Device exposure: Wearable inertial sensor monitoringAdults with essential tremor who complete clinic-based assessment and wearable monitoring, with home monitoring for 3, 7, or 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device exposure: Wearable inertial sensor monitoringPD-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. | Device | Essential Tremor cohort (n=20), Parkinson's disease cohort (n=40) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Completeness of paired home wearable and diary data
Time frame: Home monitoring period, up to 21 days.
Completeness of paired pre-dose and post-dose wearable data
Time frame: Day 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Bernassau study chair
Heriot-Watt University
Gordon Duncan principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder), run by Heriot-Watt University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gordon Duncan (+44 131 537 3804, gordon.duncan2@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearable sensor data completeness for tremor and upper-limb movement analysis (time frame: Day 1 through completion of home monitoring, up to 22 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.