Parkinson Disease
Conditions
Brief summary
This is a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated 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.
Detailed description
This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. 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 available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 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 during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). 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.
Interventions
OTHERNeuraLight
NeuraLight software-based platform
Sponsors
NeuraLight
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All patients will be assessed with MDS-UPDRS and oculometric examination over time
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Men and women with idiopathic PD (Hoehn & Yahr scale 1-3) * Age between 18 and 85 years old * Normal or corrected vision * Ability to follow instructions * Willing and able to sign an informed consent form
Exclusion criteria
* Inability to sit for 30 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of smooth pursuit speed over time as evaluated during visits | 12 months | 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 |
| Change of saccadic latency over time as evaluated during visits | 12 months | 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 |
| Change of anti-saccadic error rates over time as evaluated during visits | 12 months | 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 |
| Correlation between MDS-UPDRS score and its parts with smooth pursuit | 12 months | The correlation between MDS-UPDRS score 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 |
| Correlation between MDS-UPDRS score and its parts with saccadic latency | 12 months | The correlation between MDS-UPDRS score 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 the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits |
| Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates | 12 months | The correlation between MDS-UPDRS score 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint | 12 months | Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of MDS-UPDRS with a relative root mean square error (RMSE) of \<0.1 |
Countries
Israel
Outcome results
None listed