Modulation of Brain Blood Flow Using Dichoptic Visual and... | NCT03632564

Studies
Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation

NCT03632564

Sponsor

Visior Technologies Ltd.

Status

Unknown status

Last Update Posted

Aug 15, 2018Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Cerebral Arterial Diseases

Interventions

REVIVIEW dichoptic audio-visual stimulation

Countries

Israel

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

Aug 2018

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

Oct 10, 2018Estimated

Primary Completion Date

Jul 15, 2019Estimated

Completion Date

Aug 15, 2019Estimated

First Submitted Date

Aug 11, 2018

First Submission Date that Met QC Criteria

Aug 14, 2018

First Posted Date

Aug 15, 2018Actual

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

Aug 14, 2018

Last Update Posted Date

Aug 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.

Detailed Description

The participant will undergo baseline MRI to measure blood flow in the brain for comparison later on. After baseline MRI, the participant will observe stimulation using the REVIVIEW system for 20 minutes. The content the participants will see is a nature documentary, after which the participant will undergo additional MRI imaging to assess the change in blood flow in the brain.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stimulation Arm	Experimental	REVIVIEW dichoptic audio-visual stimulation	Device: REVIVIEW dichoptic audio-visual stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
REVIVIEW dichoptic audio-visual stimulation	Device	REVIVIEW dichoptic audio-visual stimulation using video goggles	Stimulation Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in blood flow in the brain in respond to the stimulation	Evaluate the change in blood flow in different parts of the brain, compared with baseline, after the cessation of stimulation, after 30 minutes and after 60 minutes.	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

History of brain diseases
Glasses
Diagnosed with Diabetes
Diagnosed with Degenerative brain diseases
Inability to undergo MRI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arie Orenstain, Prof.	Contact	972-3-5302993		Arie.Orenstain@sheba.health.gov.il
Yael Mardor, PhD	Contact	972-3-5302993		yael.mardor@sheba.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan		52621	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002539	Cerebral Arterial Diseases

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided