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
About this trial
This is an interventional basic science trial for Parkinson Disease
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).
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
NCT ID
NCT04212637
First Posted
October 30, 2018
Last Updated
November 16, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition
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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