Study of Eye Movements as Markers of the Physiological, C... | NCT04325971

Studies
Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects

NCT04325971

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

May 9, 2022Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Neuroimaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2020Actual

Primary Completion Date

Jul 22, 2021Actual

Completion Date

Jul 22, 2021Actual

First Submitted Date

Mar 25, 2020

First Submission Date that Met QC Criteria

Mar 27, 2020

First Posted Date

Mar 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2022

Last Update Posted Date

May 9, 2022Actual

Name	Class
Grenoble Institut des Neurosciences	OTHER
GIPSA-LAB	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is the multimodal exploration via eyetracking, MRI and EEG data of ocular movements and the corresponding brain activation during ecologic visual stimulation in the healthy population.

Detailed Description

Cerebral activation following visual stimulation is explored using two neuroimaging techniques EEG and MRI while eye movements are recorded. Three experiments are performed: in MR scanner 1) functional localisation of specific areas: LOC, FFA, MT/V5, V1 and V2 and 2) a saccadic choice experiment; with EEG, replication of the experiments performed in the MR scanner and 3) an additional experiment of movement detection during the ocular saccades.

Thirty young volunteers (18-40 y old) are involved.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Subjects	Experimental	All healthy subject are gathered in one arm	Other: Neuroimaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuroimaging	Other	MR, EEG recordings	Healthy Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eye movement brain networks	Identification of the cerebral locus of ocular movement via MRI & EEG	24 months

Secondary Outcomes

Measure	Description	Time Frame
OculoDB	Database repository of healthy population	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal vision or corrected to normal
Social security affiliation
Signed consent to participate
No pregnancy fo women

Exclusion Criteria:

Audition and motor troubles
Incapable to decide (Persons mentioned in L1121-5,6 et 8 of public health code)
Neurological disorders
Pathology affecting oculomotor control
MRI incompatibility

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sara MEONI, PH	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Grenoble Alpes		Grenoble		38043	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059906	Neuroimaging

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003943	Diagnostic Techniques, Neurological

Browse Leaves

Not provided

Browse Branches

Not provided