RECRUITING

Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and Clinical Assessment in Patients With Idiopathic Parkinson's Disease (PALOMA Trial)

Quick Facts

Study Start:2023-08-21
Study Completion:2024-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05862649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2)
  2. * Age between 40 and 85 years old
  3. * 0 to 5 years' time since diagnosis
  4. * Normal or corrected vision
  5. * Ability to follow instructions
  6. * Willing and able to sign an informed consent form
  7. * No anticipated changes in PD medications from baseline throughout the study duration based on clinical status during screening
  8. * If treated, stable on treatment for at least 3 months
  1. * Inability to sit for 40 minutes on a chair in a calm manner
  2. * Personal or 1st degree relative history of epilepsy
  3. * Additional neurological diseases
  4. * Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date)
  5. * Pregnancy or a potential pregnancy (self-declaration)

Contacts and Locations

Study Contact

Eitan Raveh, PhD
CONTACT
00972586277944
eitan@neuralight.ai

Principal Investigator

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

Study Locations (Sites)

Rush University
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: NeuraLight

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-21
Study Completion Date2024-11-15

Study Record Updates

Study Start Date2023-08-21
Study Completion Date2024-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease