A study to measure eye movements in Parkinson's Disease
Research type
Research Study
Full title
A Multicenter Longitudinal Study to Evaluate the Correlation between Oculometric Measures and Clinical Assessment in Patients with Idiopathic Parkinson's Disease (PALOMA trial).
IRAS ID
330179
Contact name
Richard Armstrong
Contact email
Sponsor organisation
NeuraLight Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Parkinson's disease (PD) is a complicated illness in which nerve cells in parts of the brain die off slowly over many years for uncertain reasons. Many studies have found that people with PD have difficulty controlling their eye movements, and they have identified connections between abnormal eye movements and specific regions of the brain affected by PD. However, the methods used in previous studies to investigate these eye movement abnormalities require specialised equipment and laboratory settings, which makes it challenging to incorporate them into clinical studies for PD. NeuraLight has developed new software that enables the collection of this data with minimal inconvenience to patients participating in clinical studies. By analysing this data, it may be possible to improve the diagnosis and monitoring of people with PD, as it could help distinguish between different types of neurodegenerative diseases and healthy individuals.
The study will collect observational data that will be used to see if there is a correlation between oculometric measurements using NeuraLight's software, and clinical measures in PD patients. The study aims to demonstrate whether the extraction and measurement of micro eye movements (oculometric measures) could detect deterioration in patients faster than the currently available clinical assessment tools.
Participants who have been diagnosed with PD within the last 5 years between the ages of 40–85 will be eligible to take part. All study participants will undergo clinical assessments (using the MDS-UPDRS and MoCA tests) over a 12-month period, with assessments conducted at 0, 3, 6, 9, and 12 months during clinic visits. Additionally, participants will have a NeuraLight session, which involves oculometric measurements and eye-tracking recordings using a software-based platform and an eye-tracking system. The oculometric evaluation and clinical assessment will take place at the beginning of the study and every 3 months for each participant.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0167
Date of REC Opinion
28 Jul 2023
REC opinion
Favourable Opinion