Parkinson's DiseaseOMTinPDNCT06051877
Ocular Microtremor in Parkinson's Disease.
An observational study of Parkinson's Disease and Parkinson Disease, run by Northumbria University at 2 sites in United Kingdom.
Trial summary
This is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Parkinson Disease
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2023to 30 Sep 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be a volunteer sample recruited from Northumbria Healthcare and Gateshead Health NHS foundation trusts. These clinics are run by Professor Richard Walker and Dr Claire McDonald (consultant geriatricians) respectively. Participants will be seen in clinic by a Movements Disorders specialist at these sites where people referred for suspected PD diagnosis and those with diagnosed PD will be identified. Potential participants will be invited to consider the study and referred to the investigators who will attend the clinics. Healthy controls could include spouses/ siblings/ other volunteer older adults.
Who may be able to join
- People with suspected PD
- People with confirmed PD
- Healthy controls
- No history of head trauma
Who cannot join
- PD and older adult participants will be excluded if there is any psychiatric co-morbidity,
- a history or evidence of head injury or ocular disease (such as cataracts),
- they have a clinical diagnosis of dementia or other severe cognitive impairment (measured using the MoCA with a score of <21).
Trial locations and contacts
2 sites in 1 country.
Rosie Morris, PhD contact
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Gateshead Health NHS Foundation Trust
Gateshead, Tyne and Wear, NE8 4YL
Claire McDonald, claire.mcdonald2@nhs.net
Lisa Graham
- Recruiting
Northumbria Healthcare NHS Trust
North Shields, Tyne and Wear, NE29 8NH
Richard Walker, richard.walker@northumbria-healthcare.nhs.uk
Lisa Graham
About this study
Official title: Ocular Microtremor in Parkinson's Disease
This is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive, motor (using the UPDRS-III) and OMT measures. With OMT as the primary outcome, assessment with the iTremor is incredibly quick, taking just three seconds to obtain a reading. PwPD will be assessed both 'off' and on their anti-parkinsonian medication. 'Off' is defined as a 12Hr overnight washout period where participants are tested in the morning prior to their first dose. PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance, gait, and turning using wearable sensors. 40 PwPD, 20 with suspected PD, and 40 age-matched healthy control participants will be recruited for assessment of OMT. Ten PwPD will complete a test-retest reliability assessment at the same approx. time, exactly one week after their initial visit.
Read the detailed description
Ocular microtremor (OMT) is a fixational eye movement that cannot be seen with the naked eye but is always present, even when the eye appears motionless/still. The link between OMT and brain function generates a strong rationale for investigation as there lies potential for its use as a biomarker in populations of neurological impairments. OMT frequency is typically 70-80Hz in healthy adults and research suggests that this will be reduced in those with neurological disease such as Parkinson's Disease (PD). This study aims to examine OMT in people with PD (PwPD) compared to healthy older adults. Identifying OMT as a PD biomarker could better support clinical assessment, enabling improved provision of care to patients with advanced disease monitoring.
This is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive, motor (using the UPDRS-III) and OMT measures. With OMT as the primary outcome, assessment with the iTremor is incredibly quick, taking just three seconds to obtain a reading. PwPD will be assessed both off and on their anti-parkinsonian medication. PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance, gait, and turning using wearable sensors. The Investigators will recruit 40 PwPD, 20 suspected PD, and 30 age-matched healthy control participants for assessment of OMT. Ten PwPD will complete a test-retest reliability assessment at the same approx. time, exactly one week after their initial visit.
This will be the first study of its kind to non-invasively investigate OMT frequency as a marker/monitor for PD with advanced technology that could be used within the clinic, laboratory, or home.
- Conditions
- Parkinson's Disease, Parkinson Disease
- Keywords
- Ocular microtremor, Eye movements, Biomarker, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| suspPD | People referred to clinic with suspected PD | |
| confPD | People with confirmed PD | |
| HC | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
OMT frequency (Hz)
Ocular mictoremor frequency (Hz) as measures with the iTremor ONE device
Measured: 2 weeksw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies 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
- 40 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust, Gateshead Health NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Samuel Stuart, PhD, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051877
- Sponsor's protocol ID
- OMT in PD
- Acronym
- OMTinPD
- Status last verified
- Apr 2024
- First submitted
- 18 Sep 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Publications
Graham L, Vitorio R, Walker R, Godfrey A, Morris R, Stuart S. Digital measurement of ocular microtremor in Parkinson's disease: Protocol for a pilot study to assess reliability and clinical validation. PLoS One. 2025 Jan 8;20(1):e0313452. doi: 10.1371/journal.pone.0313452. eCollection 2025.
PubMed 39775540
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Microtremor in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06051877
- Acronym / sponsor ID
- OMTinPD / OMT in PD
- Conditions
- Parkinson's Disease, Parkinson Disease
- Keywords
- Ocular microtremor, Eye movements, Biomarker, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust, Gateshead Health NHS Foundation Trust
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Sep 2023 (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 is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive, motor (using the UPDRS-III) and OMT measures. With OMT as the primary outcome, assessment with the iTremor is incredibly quick, taking just three seconds to obtain a reading. PwPD will be assessed both 'off' and on their anti-parkinsonian medication. 'Off' is defined as a 12Hr overnight washout period where participants are tested in the morning prior to their first dose. PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance, gait, and turning using wearable sensors. 40 PwPD, 20 with suspected PD, and 40 age-matched healthy control participants will be recruited for assessment of OMT. Ten PwPD will complete a test-retest reliability assessment at the same approx. time, exactly one week after their initial visit.
Detailed description
Ocular microtremor (OMT) is a fixational eye movement that cannot be seen with the naked eye but is always present, even when the eye appears motionless/still. The link between OMT and brain function generates a strong rationale for investigation as there lies potential for its use as a biomarker in populations of neurological impairments. OMT frequency is typically 70-80Hz in healthy adults and research suggests that this will be reduced in those with neurological disease such as Parkinson's Disease (PD). This study aims to examine OMT in people with PD (PwPD) compared to healthy older adults. Identifying OMT as a PD biomarker could better support clinical assessment, enabling improved provision of care to patients with advanced disease monitoring.
This is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive, motor (using the UPDRS-III) and OMT measures. With OMT as the primary outcome, assessment with the iTremor is incredibly quick, taking just three seconds to obtain a reading. PwPD will be assessed both off and on their anti-parkinsonian medication. PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance, gait, and turning using wearable sensors. The Investigators will recruit 40 PwPD, 20 suspected PD, and 30 age-matched healthy control participants for assessment of OMT. Ten PwPD will complete a test-retest reliability assessment at the same approx. time, exactly one week after their initial visit.
This will be the first study of its kind to non-invasively investigate OMT frequency as a marker/monitor for PD with advanced technology that could be used within the clinic, laboratory, or home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| suspPD | – | –People referred to clinic with suspected PD |
| confPD | – | –People with confirmed PD |
| HC | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be a volunteer sample recruited from Northumbria Healthcare and Gateshead Health NHS foundation trusts. These clinics are run by Professor Richard Walker and Dr Claire McDonald (consultant geriatricians) respectively. Participants will be seen in clinic by a Movements Disorders specialist at these sites where people referred for suspected PD diagnosis and those with diagnosed PD will be identified. Potential participants will be invited to consider the study and referred to the investigators who will attend the clinics. Healthy controls could include spouses/ siblings/ other volunteer older adults.
Key inclusion criteria (4 listed)
- People with suspected PD
- People with confirmed PD
- Healthy controls
- No history of head trauma
Key exclusion criteria (3 listed)
- PD and older adult participants will be excluded if there is any psychiatric co-morbidity,
- a history or evidence of head injury or ocular disease (such as cataracts),
- they have a clinical diagnosis of dementia or other severe cognitive impairment (measured using the MoCA with a score of <21).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OMT frequency (Hz)
Time frame: 2 weeksw
Ocular mictoremor frequency (Hz) as measures with the iTremor ONE device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 39775540Graham L, Vitorio R, Walker R, Godfrey A, Morris R, Stuart S. Digital measurement of ocular microtremor in Parkinson's disease: Protocol for a pilot study to assess reliability and clinical validation. PLoS One. 2025 Jan 8;20(1):e0313452. doi: 10.1371/journal.pone.0313452. eCollection 2025.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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. This study is not recruiting at the moment.
Rosie Morris, PhD contact
Samuel Stuart, PhD principal investigator
Employee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinson Disease, run by Northumbria University at 2 sites 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Graham, BSc (+44 7972257940, lisa4.graham@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OMT frequency (Hz) (time frame: 2 weeksw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051877, which also lists 1 linked publication.
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 19 Apr 2024.