VitalFlow Healthy Volunteer Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03487393

Enrollment

Registered

2018-04-04

Start date

2015-10-19

Completion date

2016-01-08

Last updated

2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Subject / Healthy Volunteers

Keywords

facial nerve, magnetic stimulation, cerebral blood flow

Brief summary

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: 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.

Interventions

DEVICEmagnetic facial nerve stimulation

Magnetic stimulation of facial nerve.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

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

* 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)

Design outcomes

Primary

Measure	Time frame	Description
Change in perfusion index of cerebral blood flow	10 minutes post-stimulation	An algorithm to calculate the perfusion index using magnetic resonance images across the entire brain

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026