Evaluating eye measurements and clinical assessments in Parkinson's disease
A Multicenter Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and Clinical Assessment in Patients With Idiopathic Parkinson's Disease (PALOMA Trial)
This study is testing if eye measurements can help track changes in people with Parkinson's disease faster than traditional clinical assessments over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | NeuraLight Industry-sponsored |
| Locations | 5 sites (Chicago, Illinois and 4 other locations) |
| Trial ID | NCT05862649 on ClinicalTrials.gov |
What this trial studies
This multicenter longitudinal study involves approximately 300 patients with idiopathic Parkinson's disease who will undergo clinical assessments and oculometric examinations at various clinical centers over a 12-month period. The study aims to evaluate the correlation between oculometric measures and clinical assessments, such as the MDS-UPDRS and MoCA scores, to determine if eye measurements can detect changes in clinical status more rapidly than current assessment tools. Participants will be assessed at five intervals (0, 3, 6, 9, and 12 months) using a novel eye-tracking system. All assessments will be conducted during clinic visits unless remote assessments are authorized.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 40 to 85 with idiopathic Parkinson's disease in the early stages of the condition.
Not a fit: Patients with additional neurological diseases or those unable to comply with the study's requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a faster and more accurate method for detecting clinical deterioration in Parkinson's disease patients.
How similar studies have performed: While the approach of using oculometric measures in Parkinson's disease is innovative, similar studies have shown promise in correlating eye movements with neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2) * Age between 40 and 85 years old * 0 to 5 years' time since diagnosis * Normal or corrected vision * Ability to follow instructions * Willing and able to sign an informed consent form * No anticipated changes in PD medications from baseline throughout the study duration based on clinical status during screening * If treated, stable on treatment for at least 3 months Exclusion Criteria: * Inability to sit for 40 minutes on a chair in a calm manner * Personal or 1st degree relative history of epilepsy * Additional neurological diseases * Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date) * Pregnancy or a potential pregnancy (self-declaration)
Where this trial is running
Chicago, Illinois and 4 other locations
- Rush University — Chicago, Illinois, United States (Recruiting)
- AIBILI research center — Coimbra, Portugal (Recruiting)
- Instituto de Biomedicina de Sevilla (IBiS) — Sevilla, Spain (Recruiting)
- University Hospital Zürich — Zürich, Switzerland (Not_yet_recruiting)
- The VCTC — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Christina Januário, MD — University of Coimbra
- Study coordinator: Eitan Raveh, PhD
- Email: eitan@neuralight.ai
- Phone: 00972586277944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.