RecruitingNCT06051877

Ocular Microtremor in Parkinson's Disease.

Ocular Microtremor in Parkinson's Disease


Sponsor

Northumbria University

Enrollment

40 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria3

  • 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).

Locations(2)

Gateshead Health NHS Foundation Trust

Gateshead, Tyne and Wear, United Kingdom

Northumbria Healthcare NHS Trust

North Shields, Tyne and Wear, United Kingdom

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NCT06051877


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