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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • CHU Grenoble-Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Volunteers

Parkinson patient

Arm Description

MRI exam

MRI exam

Outcomes

Primary Outcome Measures

MRI images
Functional and anatomical brain volumes

Secondary Outcome Measures

Eye latency
latency (milliseconds) of ocular saccades
eye amplitude
amplitude (degree) of ocular saccades

Full Information

First Posted
October 30, 2018
Last Updated
November 16, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition
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1. Study Identification

Unique Protocol Identification Number
NCT04212637
Brief Title
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
Acronym
eyebrainpark
Official Title
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
MRI exam
Arm Title
Parkinson patient
Arm Type
Experimental
Arm Description
MRI exam
Intervention Type
Other
Intervention Name(s)
MRI
Other Intervention Name(s)
eyetracking
Intervention Description
Examine BOLD activity in relation to eye movements measures
Primary Outcome Measure Information:
Title
MRI images
Description
Functional and anatomical brain volumes
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Eye latency
Description
latency (milliseconds) of ocular saccades
Time Frame
1 hour
Title
eye amplitude
Description
amplitude (degree) of ocular saccades
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole PEYRIN, PhD
Phone
(0)4 7682-5879
Ext
0033
Email
carole.peyrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Louise KAUFFMANN
Email
louise.kauffmann@gmail.com
Facility Information:
Facility Name
CHU Grenoble-Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiphaine Montagnon
Phone
476766814
Ext
0033
Email
tmontagnon@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Arnaud ATTYE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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