Cerebral Arterial DiseasesNCT03632564
Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation
A study testing REVIVIEW dichoptic audio-visual stimulation in people with Cerebral Arterial Diseases, run by Visior Technologies Ltd. at 1 site in Israel.
Trial summary
Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Arterial Diseases
- What is being tested?
- REVIVIEW dichoptic audio-visual stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Oct 2018to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
Who cannot join
- History of brain diseases
- Glasses
- Diagnosed with Diabetes
- Diagnosed with Degenerative brain diseases
- Inability to undergo MRI
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan, 52621
Yael Mardor, PhD, 97235302993 ext. 97235302993, yael.mardor@sheba.health.gov.il
Arie Orenstain, Prof.
About this study
Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.
Read the 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.
- Conditions
- Cerebral Arterial Diseases
- Being tested
- REVIVIEW dichoptic audio-visual stimulation
- Medical subject headings
- Cerebral Arterial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVIVIEW dichoptic audio-visual stimulationDevice
REVIVIEW dichoptic audio-visual stimulation using video goggles
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Arm | Experimental | REVIVIEW dichoptic audio-visual stimulation Receives: Device: REVIVIEW dichoptic audio-visual stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Oct 2018 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arterial DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Visior Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632564
- Sponsor's protocol ID
- SMC-5167-18
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation
- ClinicalTrials.gov ID
- NCT03632564
- Acronym / sponsor ID
- SMC-5167-18
- Conditions
- Cerebral Arterial Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Visior Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation Arm | Experimental | Device: REVIVIEW dichoptic audio-visual stimulationREVIVIEW dichoptic audio-visual stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (5 listed)
- History of brain diseases
- Glasses
- Diagnosed with Diabetes
- Diagnosed with Degenerative brain diseases
- Inability to undergo MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REVIVIEW dichoptic audio-visual stimulationREVIVIEW dichoptic audio-visual stimulation using video goggles | Device | Stimulation Arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVIVIEW dichoptic audio-visual stimulation in people with Cerebral Arterial Diseases, run by Visior Technologies Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arie Orenstain, Prof. (972-3-5302993, Arie.Orenstain@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood flow in the brain in respond to the stimulation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.