Unstructured Eye Tracking as a Diagnostic and Prognostic Biomarker in Parkinsonian Disorders

NCT05638477 | Unknown

• 1 other identifier: 1/378/2317
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Study Rationale: No accurate tests currently exist to diagnose Parkinson's disease (PD) and the conditions which mimic it (atypical parkinsonism) at a very early stage. Similarly there are no accurate ways to track how these diseases progress in a very precise manner. Recording eye movements and pupils may be a very sensitive way of doing this and may contain important information about a patient's diagnosis and their cognitive and motor function. Hypothesis: We hypothesize that measuring eye movements and pupil changes while people watch short video clips will differentiate PD and atypical parkinsonism at an early stage. We hypothesize that eye movements and pupil changes will be able to track how a person's disease changes over time and could even predict their disease course from the start. Before we can do this, we need to be able to accurately differentiate between PD and atypical parkinsonism and see how eye movements vary among people with the same disease. Study Design: We will ask a large number of people with PD and atypical parkinsonism to watch very brief video clips while we record eye movements and pupil responses. This is like changing the television channel every few seconds and observing what happens to a person's eyes as they search the new clip. We will compare these results between different disease groups and correlate them with clinical features of PD and atypical parkinsonism. Impact on Diagnosis/Treatment of Parkinson's disease: This may have enormous impact in the assessment of people with PD. It may become an important diagnostic tool, a prognostic marker at the early stage of disease, as well as providing the ability to track disease progression in clinical trials. Next Steps for Development: Once we can demonstrate that eye tracking can differentiate these conditions, we will follow a large number of patients to see how their eye movements and pupils change over time with their disease. If this is a reliable way to track disease it could be used to measure disease progression in these conditions and response to treatment.

Conditions

Parkinson's Disease and Parkinsonism; Progressive Supranuclear Palsy; Multiple System Atrophy; Corticobasal Degeneration

Outcome Measures

Primary Outcomes (5)

• Amplitude of saccadic eye movements (in degrees) measured by Eyelink 1000 eye tracker during free viewing of videos.

  Amplitude of saccadic eye movements (in degrees) measured by Eyelink 1000 eye tracker during free viewing of videos.

  24 months

• Pupil Constriction (in mm) measured by Eyelink 1000 eye tracker during free viewing of videos.

  Pupil Constriction (in mm) measured by Eyelink 1000 eye tracker during free viewing of videos.

  24 months

• Blink Rate (blinks/second) measured by Eyelink 1000 eye tracker during free viewing of videos.

  Blink rate (blinks/second) measured by eye tracker during free viewing of videos.

  24 months

• Velocity of saccadic eye movements (in degrees/second) measured by Eyelink 1000 eye tracker during free viewing of videos.

  Velocity of saccadic eye movements (in degrees/second) measured by Eyelink 1000 eye tracker during free viewing of videos.

  24 months

• Pupil dilatation (in mm) measured by Eyelink 1000 eye tracker during free viewing of videos.

  Pupil dilatation (in mm) measured by Eyelink 1000 eye tracker during free viewing of videos.

  24 months

Study Arms (4)

Parkinson's disease

EXPERIMENTAL

Eye tracking using Eyelink 1000 during free-viewing of videos

Behavioral: Free-viewing eye tracking

Progressive Supranuclear Palsy

EXPERIMENTAL

Eye tracking using Eyelink 1000 during free-viewing of videos

Behavioral: Free-viewing eye tracking

Multiple System Atrophy

EXPERIMENTAL

Eye tracking using Eyelink 1000 during free-viewing of videos

Behavioral: Free-viewing eye tracking

Corticobasal Syndrome

EXPERIMENTAL

Eye tracking using Eyelink 1000 during free-viewing of videos

Behavioral: Free-viewing eye tracking

Interventions

Free-viewing eye tracking BEHAVIORAL

Participants will watch 20 minutes of video clips while their eye movements, pupil size and blink rate are recorded

Corticobasal Syndrome; Multiple System Atrophy; Parkinson's disease; Progressive Supranuclear Palsy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attending or referred to the Movement Disorder Clinic at the Mater Misericordiae University Hospital
• Current diagnosis of PD, PSP, MSA, CBS.
• Participant can give informed written consent. All participants must be capable of understanding and complying with the requirements of the protocol, including ability to attend for all visits.
• Participants have a minimum Montreal Cognitive Assessment score of ≥16
• All participants must have visual acuity in at least one eye such that they can identify stimuli presented on a computer screen in front of them.
• Participants must be able to sit comfortably for a period of about 20 minutes

You may not qualify if:

• Participant has large visual field defects that obscure visual targets within ±10 degrees of central vision.
• Participants has cognitive impairments that prohibit them from understanding the task description.
• History of stroke, traumatic brain injury or other condition which may interfere with eye movements.
• History of photosensitive epilepsy

Sponsors & Collaborators

• Conor Fearon: lead
• Queen's University: collaborator

Study Sites (1)

Dublin Neurological Institute at the Mater Misericordiae University Hospital

Dublin, Leinster, D07W7XF, Ireland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Multiple System Atrophy; Corticobasal Degeneration

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Conor Fearon, MB PhD

  Dublin Neurological Institute at the Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Inocentes

CONTACT

+35318545038; JohnInocentes@dni.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 6, 2022
• Study Start: December 1, 2022
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)