NeuraLight Eye Exam for Parkinson's Disease

(PALOMA Trial)

Recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how eye exams can track Parkinson's disease over time. Researchers aim to determine if changes in eye movement reveal early shifts in the disease's progression. The study focuses on individuals diagnosed with Parkinson's disease within the last five years, who have stable treatment plans and good vision. Participants will undergo regular eye exams using NeuraLight technology and clinical assessments to examine the relationship between eye movements and Parkinson's symptoms. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could enhance early detection and management of Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires that you do not change your Parkinson's disease medications during the study. If you are on treatment, it should be stable for at least 3 months before joining the trial.

What prior data suggests that the NeuraLight Eye Exam is safe for evaluating Parkinson's disease?

Research has shown that using NeuraLight for eye exams in Parkinson's patients is likely safe. In a study with 215 participants, researchers compared NeuraLight's eye tests to standard methods for assessing Parkinson's severity. They reported no safety issues or negative effects.

This study focuses on tracking eye movements, a non-invasive method. It does not involve anything entering the body, so the risks are generally lower. The study does not involve a new drug or surgery but rather a new way to observe changes in the eyes.

Since NeuraLight is not a medication, it lacks the side effects that drugs might have. The focus is on observing eye movements to monitor Parkinson's progression, minimizing the chance of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NeuraLight Eye Exam for Parkinson's Disease because it offers a novel approach to monitoring and potentially diagnosing the condition. Unlike traditional methods that rely heavily on observing motor symptoms or performing complex brain scans, NeuraLight uses eye-tracking technology to provide insights into neurological changes. This non-invasive and potentially quicker method could lead to earlier detection and better management of Parkinson's, setting it apart from the standard practices used today.

What evidence suggests that the NeuraLight eye exam is effective for Parkinson's disease?

Research shows that eye measurements, such as those used by NeuraLight, detect changes in Parkinson's disease faster than traditional methods. One study found a recall rate of 97.65% and an accuracy of 92.73% with these measurements. Eye tracking serves as a reliable and cost-effective tool for early detection and assessment of Parkinson's disease. Studies suggest this method can identify changes in movement and cognition, providing a new way to monitor the disease over time. Overall, these findings support the potential of NeuraLight's eye exams to effectively track Parkinson's disease progression. ^{3 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

My vision is normal or corrected to normal.

I am between 40 and 85 years old.

Exclusion Criteria

Pregnancy or a potential pregnancy (self-declaration)

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05795023

A Longitudinal Evaluation of Oculometric Measures and ... The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11731183/

Diagnosis of Parkinson's disease by eliciting trait-specific ... The performance of the models was evaluated through cross-validation, revealing a recall of 97.65%, an accuracy of 92.73%, and a receiver ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06597071?utm_source=chatgpt.com

Study Details | NCT06597071 | Parkinson Atypical Rating ... The aim of the study is to assess the difference of oculometric measures in different neurodegenerative brain conditions and their accuracy over time, and as ...

4. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2025.1534073/full

Recent advances (2022–2024) in eye-tracking for ... This systematic review evaluates the effectiveness of eye-tracking in assessing motor and cognitive alterations associated with PD.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12025636/

Eye Tracking in Parkinson's Disease: A Review of Oculomotor ... (5) Conclusions. Eye tracking provides a reliable, cost-effective tool for early PD detection, cognitive assessment, and rehabilitation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133813/

Recent advances (2022–2024) in eye-tracking for Parkinson's ... PD patients showed slower saccades, higher error rates, and impaired visual scanning with prolonged fixation duration and fewer fixations. A VR- ...

7. parkinsonsnewstoday.com parkinsonsnewstoday.com/news/parkinsons-progression-may-be-tracked-measuring-eye-movements/

Parkinson's progression may be tracked by measuring eye ... A study of 215 people with Parkinson's assessed whether NeuraLight's test scores matched standard assessments of disease severity.

8. drugtargetreview.com drugtargetreview.com/article/188266/eye-movements-as-objective-biomarkers-accelerating-cns-drug-development/

Eye movements as objective biomarkers: accelerating CNS ... Eye movements as an endpoint in clinical trials​​ In another Parkinson's study, progressive saccadic hypometria was detected over nine months, ...

9. nature.com nature.com/articles/s41531-023-00625-7

Machine Learning in the Parkinson's disease smartwatch ... A multi-modal smartphone app integrated electronic questionnaires and smartwatch measures during an interactive assessment designed by neurologists.