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

November 16, 2020 updated by: University Hospital, Grenoble
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble-Alpes
        • Contact:
        • Principal Investigator:
          • Arnaud ATTYE, MD

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 hour
Functional and anatomical brain volumes
1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Laboratoire de Psychologie et NeuroCognition

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 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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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