VitalFlow Healthy Volunteer Study

Normal Subject / Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487393
• Other study ID #: NRV_PI_01_15
• Status: Completed
• Phase: N/A
• First received: June 17, 2017
• Last updated: March 27, 2018
• Start date: October 19, 2015
• Est. completion date: January 8, 2016

Study information

• Verified date: March 2018
• Source: Nervive, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 8, 2016
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Normal Subject / Healthy Volunteers

Intervention

Device:
• magnetic facial nerve stimulation
Magnetic stimulation of facial nerve.

Locations

Country	Name	City	State
Mexico	Centro Nacional de Investigación en Imagenología e Instrumentación Medica	Mexico City	Cdmx

Sponsors (2)

Lead Sponsor	Collaborator
Nervive, Inc.	Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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