Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation

August 14, 2018 updated by: Visior Technologies Ltd.
Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Arie Orenstain, Prof.
        • Sub-Investigator:
          • Yael Mardor, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stimulation Arm
REVIVIEW dichoptic audio-visual stimulation
Device: REVIVIEW dichoptic audio-visual stimulation
REVIVIEW dichoptic audio-visual stimulation using video goggles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood flow in the brain in respond to the stimulation
Time Frame: 1 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Visior Technologies Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 10, 2018

Primary Completion (ANTICIPATED)

July 15, 2019

Study Completion (ANTICIPATED)

August 15, 2019

Study Registration Dates

First Submitted

August 11, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (ACTUAL)

August 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-5167-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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