An interventional study of NeuraLight in Parkinson Disease, sponsored by NeuraLight. Completed at 5 sites in 5 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by NeuraLight · Not applicable, Interventional, and Other
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.
This is an multicenter longitudinal study, in about 300 patients with idiopathic PD in several centers. The aim of this study is to evaluate the correlations between oculometric measures and clinical assessment, e.g. the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the MoCA score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. In addition, the investigators aim to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. All patients will be assessed over a period of 12 months (5 assessments, at 0, 3, 6, 9, 12 months). During this time period, every subject who consents will undergo a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye- tracking system (Tobii, CE-marked class B approved device) (approx. 30 minutes). The oculometric evaluation will occur for every patient every 3 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 300 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2) aged 40-85 years
Other: NeuraLight
NeuraLight software-based platform
Change of saccadic latency over time as evaluated during visits
Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Time frame: 12 months
Change of anti-saccadic error rates over time as evaluated during visits
Difference between anti-saccadic error rates (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Time frame: 12 months
Change of smooth pursuit speed over time as evaluated during visits
Difference between smooth pursuit speed (ms)as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Time frame: 12 months
Correlation between MDS-UPDRS score and its parts with saccadic latency
The correlation between the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to MDS-UPDRS scores at visits
Time frame: 12 months
Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates
The correlation between Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with anti-saccadic error rates (%), measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the MDS-UPDRS scores at visits
Time frame: 12 months
Correlation between MDS-UPDRS score and its parts with smooth pursuit
The correlation between Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with smooth pursuit speed (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Time frame: 12 months
Correlation between MoCA score and its parts with saccadic latency
The correlation between MoCA score and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation
Time frame: 12 months
Correlation between MoCA score and its parts with anti-saccadic error rates
The correlation between the Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with anti-saccadic error rates (%), measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Montreal Cognitive Assessment (MoCA) at visits
Time frame: 12 months
Correlation between MoCA score and its parts with smooth pursuit
The correlation between Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with smooth pursuit speed (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Montreal Cognitive Assessment (MoCA) at visits
Time frame: 12 months
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating ScaleMDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with a relative root mean square error (RMSE) of \<0.1
Time frame: 12 months
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MoCA clinical endpoint
Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with a relative root mean square error (RMSE) of \<0.1
Time frame: 12 months
Plan to share: No
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