NeuraLight Eye Exam for Parkinson's Disease

(PALOMA Trial)

Recruiting at 4 trial locations

Overseen By Eitan Raveh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeuraLight

Disqualifiers: Epilepsy, Neurological diseases, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinson's disease, who will be evaluated in several clinical centers with a clinical assessment and an oculometric examination during a time period with specific intervals. This study aims to evaluate the correlation between oculometric measures and clinical assessment over time, as well as the potential to detect early change in clinical status using an oculometric assessment.

Research Team

Christina Januário, MD

Principal Investigator

University of Coimbra

Richard Armstrong, MD

Principal Investigator

The VCTC

Pablo Mir, MD

Principal Investigator

Instituto de Biomedicina de Sevilla (IBiS

Michelle Tosin, PhD

Principal Investigator

Rush Medical University Center

Bettina Balint, MD

Principal Investigator

University Hospital, Zürich

Eligibility Criteria

This trial is for men and women aged 40-85 with idiopathic Parkinson's disease, diagnosed within the last five years and at early stages (Hoehn & Yahr scale 1-2). Participants must have normal or corrected vision, be able to follow instructions, not expect changes in their PD medications during the study, and if treated, be stable on treatment for at least three months.

Inclusion Criteria

I have Parkinson's disease at an early or mild stage.

Willing and able to sign an informed consent form

I have been on stable treatment for at least 3 months.

Exclusion Criteria

Personal or 1st degree relative history of epilepsy

I do not abuse drugs or alcohol, except for medical cannabis within 24 hours before my NL exam.

Pregnancy or a potential pregnancy (self-declaration)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial clinical assessment and oculometric examination to establish baseline measures

1 day

1 visit (in-person)

Oculometric Evaluation

Participants undergo oculometric measurements and eye-tracking recordings every 3 months

12 months

5 visits (in-person or remote)

Follow-up

Participants are monitored for changes in clinical status and oculometric measures

4 weeks

Treatment Details

Interventions

• NeuraLight

Trial Overview The study tests NeuraLight technology in about 300 patients across multiple centers. It aims to see if tracking eye movements (oculometric measures) can reflect clinical conditions of Parkinson's patients over time and possibly detect early changes in their health status.

Participant Groups

Group I: PD patients Experimental Treatment 1 Intervention

Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2) aged 40-85 years

Who Is Running the Clinical Trial?

NeuraLight

Lead Sponsor

Trials

6

Recruited

2,900+

European Clinical Research Infrastructure Network

Collaborator

Trials

10

Recruited

3,700+