OMT inPD: Ocular Microtremor in Parkinson's Disease.

Sponsor

Northumbria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06051877

Collaborator

Northumbria Healthcare NHS Foundation Trust (Other), Gateshead Health NHS Foundation Trust (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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. We will recruit 40 PwPD, 20 with suspected PD, and 40 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.

Condition or Disease	Intervention/Treatment	Phase
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. We 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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ocular Microtremor in Parkinson's Disease

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
suspPD People referred to clinic with suspected PD
confPD People with confirmed PD
HC Healthy controls

Outcome Measures

Primary Outcome Measures

OMT frequency (Hz) [2 weeksw]
Ocular mictoremor frequency (Hz) as measures with the iTremor ONE device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gateshead Health NHS Foundation Trust	Gateshead	Tyne And Wear	United Kingdom	NE8 4YL
2	Northumbria Healthcare NHS Trust	North Shields	Tyne And Wear	United Kingdom	NE29 8NH

Sponsors and Collaborators

Northumbria University
Northumbria Healthcare NHS Foundation Trust
Gateshead Health NHS Foundation Trust

Investigators

Principal Investigator: Samuel Stuart, PhD, Employee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Northumbria University

ClinicalTrials.gov Identifier:

NCT06051877

Other Study ID Numbers:

OMT in PD

First Posted:

Sep 25, 2023

Last Update Posted:

Sep 25, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Northumbria University

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Sep 25, 2023