Study of Eye Movements (EYE) as Early Markers of Brain Dy... | NCT04212637

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

NCT04212637

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Nov 17, 2020Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2021Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Oct 30, 2018

First Submission Date that Met QC Criteria

Dec 26, 2019

First Posted Date

Dec 27, 2019Actual

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

Nov 16, 2020

Last Update Posted Date

Nov 17, 2020Actual

Name	Class
Laboratoire de Psychologie et NeuroCognition	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

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Volunteers	Experimental	MRI exam	Other: MRI
Parkinson patient	Experimental	MRI exam	Other: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other	Examine BOLD activity in relation to eye movements measures	Healthy Volunteers Parkinson patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI images	Functional and anatomical brain volumes	1 hour

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carole PEYRIN, PhD	Contact	(0)4 7682-5879	0033	carole.peyrin@gmail.com
Louise KAUFFMANN	Contact			louise.kauffmann@gmail.com

Overall Officials

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided