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CompletedNCT03487393Updated Apr 4, 2018

VitalFlow Healthy Volunteer Study

An interventional study of magnetic facial nerve stimulation in Normal Subject / Healthy Volunteers, sponsored by Nervive, Inc.. Completed at 1 site in Mexico. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by Nervive, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study summary

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:

  1. Perform tolerability and safety tests of magnetic stimulation on the facial nerve.
  2. Establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the Magnetic Stimulation (MS) system.
  3. Measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.
02

Conditions studied

  • Normal Subject / Healthy Volunteers

Keywords

  • facial nerve
  • magnetic stimulation
  • cerebral blood flow
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects
  • Normal audiometry chart (Evaluated at the time of your inclusion).
  • Normal neurological examination at time of inclusion.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Vitalflow treatment

    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%).

    Device: magnetic facial nerve stimulation

Interventions

  • Devicemagnetic facial nerve stimulation

    Magnetic stimulation of facial nerve.

05

What researchers measure

Primary outcomes

  1. Change in perfusion index of cerebral blood flow

    An algorithm to calculate the perfusion index using magnetic resonance images across the entire brain

    Time frame: 10 minutes post-stimulation

06

Study locations

1 site
  • Centro Nacional de Investigación en Imagenología e Instrumentación Medica
    Mexico City, Cdmx 09340, Mexico
07

References and documents

Individual participant data

Plan to share: Yes — available from investigators authors upon reasonable request

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03487393
Lead sponsor
Nervive, Inc.
Collaborators
Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Oct 19, 2015
Primary completion
Dec 15, 2015
Completion
Jan 8, 2016
Last update
Apr 4, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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