Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK) (eyebrainpark)

Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: MRI

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • CHU Grenoble-Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for all:

• Visual acuity normal or corrected to normal
• Affiliation to a social security scheme (copy of the vital card in support)
• Signed informed consent
• Medical examination according to the participation in the MRI examination
• MMSE score> 23/30

For Parkinson patient:

• Diagnosis of Parkinson's disease
• Presence of asymmetric bradykinesia and rest tremor and / or stiffness
• Hoehn & Yahr Stadium I-II / V

Exclusion Criteria for all:

• Unprotected Majors unable to express their consent
• Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
• Significant hearing or motor impairment
• Past or present neuropsychiatric pathology (except benign epilepsy)
• Taking narcotics and / or drugs for neurocognitive purposes
• Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous)
• Any other neurodegenerative pathology or treatment that may affect the oculomotor control

For Parkinson patient:

• Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; MRI exam	Other: MRI; Examine BOLD activity in relation to eye movements measures; Other Names: eyetracking
Experimental: Parkinson patient; MRI exam	Other: MRI; Examine BOLD activity in relation to eye movements measures; Other Names: eyetracking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI images	Functional and anatomical brain volumes	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye latency	latency (milliseconds) of ocular saccades	1 hour
eye amplitude	amplitude (degree) of ocular saccades	1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Laboratoire de Psychologie et NeuroCognition

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: December 26, 2019
• First Posted (Actual): December 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 38RC18.214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No