Ocular Microtremor in Parkinson's Disease.

NCT06051877 | Recruiting

• 1 other identifier: OMT in PD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Parkinson's Disease; Parkinson Disease

Keywords

Ocular microtremor; Eye movements; Biomarker; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• OMT frequency (Hz)

  Ocular mictoremor frequency (Hz) as measures with the iTremor ONE device

  2 weeksw

Study Arms (3)

suspPD

People referred to clinic with suspected PD

confPD

People with confirmed PD

HC

Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• People with suspected PD
• People with confirmed PD
• Healthy controls
• No history of head trauma

You may not qualify if:

• 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).

Sponsors & Collaborators

• Northumbria University: lead
• Northumbria Healthcare NHS Foundation Trust: collaborator
• Gateshead Health NHS Foundation Trust: collaborator

Study Sites (2)

Gateshead Health NHS Foundation Trust

Gateshead, Tyne and Wear, NE8 4YL, United Kingdom

NOT YET RECRUITING

Northumbria Healthcare NHS Trust

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 39775540 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Samuel Stuart, PhD

  Employee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Graham, BSc

CONTACT

+44 7972257940; lisa4.graham@northumbria.ac.uk

Rosie Morris, PhD

CONTACT

rosie.e.morris@northumbria.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)