VitalFlow Healthy Volunteer Study

NCT03487393 | Completed

• 1 other identifier: NRV_PI_01_15
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Normal Subject / Healthy Volunteers

Keywords

facial nerve; magnetic stimulation; cerebral blood flow

Outcome Measures

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

  10 minutes post-stimulation

Study Arms (1)

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%).

Device: magnetic facial nerve stimulation

Interventions

magnetic facial nerve stimulation DEVICE

Magnetic stimulation of facial nerve.

Vitalflow treatment

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nervive, Inc.: lead
• Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M): collaborator

Study Sites (1)

Centro Nacional de Investigación en Imagenología e Instrumentación Medica

Mexico City, Mexico City, 09340, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective

Study Record Dates

• First Submitted: June 17, 2017
• First Posted: April 4, 2018
• Study Start: October 19, 2015
• Primary Completion: December 15, 2015
• Study Completion: January 8, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)