VitalFlow Healthy Volunteer Study

Not Applicable

Completed

• Conditions: Normal Subject / Healthy Volunteers
• Interventions: Device: magnetic facial nerve stimulation

• Registration Number: NCT03487393
• Lead Sponsor: Nervive, Inc.

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.

Study Timeline

• Study Start: 2015-10-19
• Primary Completion: 2015-12-15
• Study Completion: 2016-01-08
• Study First Submitted: 2017-06-17
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-27
• Last Update Submitted: 2018-03-27
• Study First Posted: 2018-04-04
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitalflow treatment	magnetic facial nerve stimulation	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%).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centro Nacional de Investigación en Imagenología e Instrumentación Medica; 🇲🇽 Mexico City, Cdmx, Mexico