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Behavioural Intervention

NeuraLight Eye Exam for Parkinson's Disease (PALOMA Trial)

N/A
Recruiting
Led By Bettina Balint, MD
Research Sponsored by NeuraLight
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PALOMA Trial Summary

This trial studies how Parkinson's changes over time & how eye exam results may predict clinical changes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-invasive oculometric assessments rather than medication or invasive procedures, significant side effects are not anticipated. However, discomfort from sitting still may occur.

PALOMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of anti-saccadic error rates over time as evaluated during visits
Change of saccadic latency over time as evaluated during visits
Change of smooth pursuit speed over time as evaluated during visits
+3 more
Secondary outcome measures
Correlation between MoCA score and its parts with anti-saccadic error rates
Correlation between MoCA score and its parts with saccadic latency
Correlation between MoCA score and its parts with smooth pursuit
+2 more

PALOMA Trial Design

1Treatment groups
Experimental Treatment
Group I: PD patientsExperimental Treatment1 Intervention
Men and women with idiopathic PD (Hoehn & Yahr scale 1-2) aged 40-85 years

Find a Location

Who is running the clinical trial?

NeuraLightLead Sponsor
4 Previous Clinical Trials
2,540 Total Patients Enrolled
European Clinical Research Infrastructure NetworkOTHER
8 Previous Clinical Trials
2,760 Total Patients Enrolled
Bettina Balint, MDPrincipal InvestigatorUniversity Hospital, Zürich

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants of any age below 35?

"Patients aged 40 to 85 are the only ones that meet this trial's inclusion criteria. There are 23 trials for those under 18 while 529 studies target individuals older than 65 years of age."

Answered by AI

How many venues are being employed to conduct this experiment?

"At present, this research venture is being conducted at 5 different sites. These include Coimbra, Sevilla and Zürich in addition to other municipalities. To minimize the burden of travel for potential participants, it would be beneficial to select a location that is geographically close by."

Answered by AI

How many individuals are being enrolled into this trial's participant pool?

"Affirmative. According to the details posted on clinicaltrials.gov, this experiment is currently recruiting participants. It was first announced on August 21st 2023 and last amended October 3rd 2023. The trial requires 300 recruits from 5 various medical facilities."

Answered by AI

Are there any vacancies available for prospective participants in the trial?

"Affirmative, clinicaltrials.gov data points to this trial presently seeking volunteers; the study first appeared on August 21st 2023 and was recently edited October 3rd 2023. This medical investigation is looking for 300 participants from 5 distinct sites."

Answered by AI

Who is the ideal cohort for participating in this experiment?

"This research project recruiting 300 patients with Parkinson's disease aged between 40 and 85. To be eligible, participants must have received their diagnosis no more than 5 years ago, display mild to moderate symptoms (Hoehn & Yahr scale 1-2), possess normal or corrected vision, understand the study information provided in order to give informed consent, remain stable on PD medications for 3 months prior to enrollment if they are already taking them."

Answered by AI

What is the ultimate goal of this research project?

"As per NeuraLight, the primary outcome being measured over 12 months is the link between MDS-UPDRS score and saccadic latency. Additionally, secondary outcomes include a correlation between Montreal Cognitive Assessment (MoCA) with smooth pursuit speed as well as optimisation of feature selection model for logistic regression modelling of MoCA via collected oculometric measures relative root mean square error below 0.1, and finally correlation between MoCA score and its parts with saccadic latency."

Answered by AI
~129 spots leftby Nov 2024