Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862649
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-05-08
Brief Title:
Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinsons Disease
Sponsor:
NeuraLight
Organization:
NeuraLight
Study Overview
Official Title:
A Multicenter Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and Clinical Assessment in Patients With Idiopathic Parkinsons Disease PALOMA Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALOMA
Brief Summary:
This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinsons 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
Detailed Description:
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 eg the Movement Disorder Society-Sponsored Revision of the Unified Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None