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OpenTrials
Completed

NCT Number: NCT03487393

VitalFlow Healthy Volunteer Study

Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Nacional de Investigación en Imagenología e Instrumentación Medica

Mexico City, 09340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)

Treatment and study plan

magnetic facial nerve stimulation

Device

Magnetic stimulation of facial nerve.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nervive, Inc.

Industry

Collaborators

  • Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)

Registry information

Official study title

Determination of Threshold of Stimulation, Tolerability and Safety of Magnetic Nerve Stimulation In Healthy Subjects: an Exploratory Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 4, 2018
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.