Ocular Microtremor in Parkinson's Disease. (OMTinPD)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Parkinson Disease

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Rosie Morris, PhD; Email: rosie.e.morris@northumbria.ac.uk
• Study Contact Backup: Name: Lisa Graham, BSc; Phone Number: +44 7972257940; Email: lisa4.graham@northumbria.ac.uk

Study Locations

• United Kingdom
  • Tyne And Wear
    • Gateshead, Tyne And Wear, United Kingdom, NE8 4YL
      • Not yet recruiting
      • Gateshead Health NHS Foundation Trust
      • Contact: Claire McDonald; Email: claire.mcdonald2@nhs.net
      • Sub-Investigator: Lisa Graham
    • North Shields, Tyne And Wear, United Kingdom, NE29 8NH
      • Recruiting
      • Northumbria Healthcare NHS Trust
      • Sub-Investigator: Lisa Graham
      • Contact: Richard Walker; Email: richard.walker@northumbria-healthcare.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
HC; Healthy controls
suspPD; People referred to clinic with suspected PD
confPD; People with confirmed PD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OMT frequency (Hz)	Ocular mictoremor frequency (Hz) as measures with the iTremor ONE device	2 weeksw

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Gateshead Health NHS Foundation Trust; Northumbria Healthcare NHS Foundation Trust
• Investigators: Principal Investigator: Samuel Stuart, PhD, Employee

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; Parkinson's Disease; Eye movements; Ocular microtremor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: OMT in PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No