VitalFlow Healthy Volunteer Study

March 27, 2018 updated by: Nervive, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Magnetic stimulation of facial nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 minutes post-stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nervive, Inc.

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2015

Primary Completion (Actual)

December 15, 2015

Study Completion (Actual)

January 8, 2016

Study Registration Dates

First Submitted

June 17, 2017

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NRV_PI_01_15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

available from investigators authors upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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