Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
eyebrainpark
1 other identifier
interventional
80
1 country
1
Brief Summary
Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jan 2021
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2019
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedNovember 17, 2020
November 1, 2020
11 months
October 30, 2018
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
MRI images
Functional and anatomical brain volumes
1 hour
Secondary Outcomes (2)
Eye latency
1 hour
eye amplitude
1 hour
Study Arms (2)
Healthy Volunteers
EXPERIMENTALMRI exam
Parkinson patient
EXPERIMENTALMRI exam
Interventions
Examine BOLD activity in relation to eye movements measures
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Grenoble-Alpes
Grenoble, 38043, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
December 27, 2019
Study Start
January 1, 2021
Primary Completion
December 1, 2021
Study Completion
January 1, 2022
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share