NCT03632564

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

August 11, 2018

Last Update Submit

August 14, 2018

Conditions

Cerebral Arterial Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Stimulation Arm

EXPERIMENTAL

REVIVIEW dichoptic audio-visual stimulation

Device: REVIVIEW dichoptic audio-visual stimulation

Interventions

REVIVIEW dichoptic audio-visual stimulationDEVICE

REVIVIEW dichoptic audio-visual stimulation using video goggles

Stimulation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Cerebral Arterial Diseases

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Arie Orenstain, Prof.

CONTACT

972-3-5302993Arie.Orenstain@sheba.health.gov.il

Yael Mardor, PhD

CONTACT

972-3-5302993yael.mardor@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2018

First Posted

August 15, 2018

Study Start

October 10, 2018

Primary Completion

July 15, 2019

Study Completion

August 15, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

IL(1)