Normal Subject / Healthy VolunteersNCT03487393
VitalFlow Healthy Volunteer Study
A study testing magnetic facial nerve stimulation in people with Normal Subject / Healthy Volunteers, run by Nervive, Inc. at 1 site in Mexico.
Trial summary
Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Subject / Healthy Volunteers
- What is being tested?
- magnetic facial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 19 Oct 2015to 8 Jan 2016
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Normal audiometry chart (Evaluated at the time of your inclusion).
- Normal neurological examination at time of inclusion.
Who cannot join
- Subjects with a diagnosis of epilepsy, seizures, facial nerve palsy, migraine or recurrent headaches, glaucoma or neuropathies.
- Subjects in breastfeeding or in pregnancy. (To be confirmed with test strip).
- Subjects with acute or acute chronic medical conditions.
- Age less than 20 years or greater than 40 years.
- Carotid surgery.
- Episodes of syncope.
Show all 10Show fewer
- Known arteriosclerosis anywhere on the body
- Metal implants (cochlear implants, pacemakers, metal prostheses).
- Intracranial abnormalities observed by MRI or MRA (Evaluated at time of inclusion of the subject).
- Intraocular pressure> 22mmHg (Evaluated at time of inclusion of the subject)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Nacional de Investigación en Imagenología e Instrumentación Medica
Mexico City, Mexico City, 09340
About this study
Official title: Determination of Threshold of Stimulation, Tolerability and Safety of Magnetic Nerve Stimulation In Healthy Subjects: an Exploratory Study
Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.
Read the detailed description
Magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes in cerebral blood flow safely, without generating adverse effects unknown to the technique.
Our specific objectives:
- Perform tolerability and safety tests of magnetic stimulation on the facial nerve.
- Establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the Magnetic Stimulation (MS) system.
- Measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.
- Conditions
- Normal Subject / Healthy Volunteers
- Being tested
- magnetic facial nerve stimulation
- Keywords
- facial nerve, magnetic stimulation, cerebral blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic facial nerve stimulationDevice
Magnetic stimulation of facial nerve.
| Study group | Role | What they receive |
|---|---|---|
| Vitalflow treatment | Experimental | The subject's exposure will be through a ramp model of increments in magnetic stimulation power delivered to the facial nerves bilaterally. Increases in magnetic stimulation will be 10% for 10 seconds from 10% to 60%. Subsequent to this will be evaluated for 5 minutes in the power of tolerability of the subject (60% 70%, 80% or 90%). Receives: Device: magnetic facial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perfusion index of cerebral blood flow
An algorithm to calculate the perfusion index using magnetic resonance images across the entire brain
Measured: 10 minutes post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start19 Oct 2015
- Primary completion15 Dec 2015
- Study completion8 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Subject / Healthy VolunteersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nervive, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487393
- Sponsor's protocol ID
- NRV_PI_01_15
- Status last verified
- Mar 2018
- First submitted
- 17 Jun 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: available from investigators authors upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Threshold of Stimulation, Tolerability and Safety of Magnetic Nerve Stimulation In Healthy Subjects: an Exploratory Study
- ClinicalTrials.gov ID
- NCT03487393
- Acronym / sponsor ID
- NRV_PI_01_15
- Conditions
- Normal Subject / Healthy Volunteers
- Keywords
- facial nerve, magnetic stimulation, cerebral blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Nervive, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 8 Jan 2016 (actual)
- First posted
- 4 Apr 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.
Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.
Detailed description
Magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes in cerebral blood flow safely, without generating adverse effects unknown to the technique.
Our specific objectives:
- Perform tolerability and safety tests of magnetic stimulation on the facial nerve.
- Establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the Magnetic Stimulation (MS) system.
- Measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Vitalflow treatment | Experimental | Device: magnetic facial nerve stimulationThe subject's exposure will be through a ramp model of increments in magnetic stimulation power delivered to the facial nerves bilaterally. Increases in magnetic stimulation will be 10% for 10 seconds from 10% to 60%. Subsequent to this will be evaluated for 5 minutes in the power of tolerability of the subject (60% 70%, 80% or 90%). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Normal audiometry chart (Evaluated at the time of your inclusion).
- Normal neurological examination at time of inclusion.
Key exclusion criteria (10 listed)
- Subjects with a diagnosis of epilepsy, seizures, facial nerve palsy, migraine or recurrent headaches, glaucoma or neuropathies.
- Subjects in breastfeeding or in pregnancy. (To be confirmed with test strip).
- Subjects with acute or acute chronic medical conditions.
- Age less than 20 years or greater than 40 years.
- Carotid surgery.
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 |
|---|---|---|
| magnetic facial nerve stimulationMagnetic stimulation of facial nerve. | Device | Vitalflow treatment |
Primary outcome
Change in perfusion index of cerebral blood flow
Time frame: 10 minutes post-stimulation
An algorithm to calculate the perfusion index using magnetic resonance images across the entire brain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: Yes. available from investigators authors upon reasonable request
Related trials for Normal Subject / Healthy Volunteers
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingPhase 1
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Atopic Dermatitis (AD), Eczema
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic facial nerve stimulation in people with Normal Subject / Healthy Volunteers, run by Nervive, Inc. at 1 site in Mexico.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 4 Apr 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perfusion index of cerebral blood flow (time frame: 10 minutes post-stimulation). 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 4 Apr 2018.