VitalFlow Healthy Volunteer Study

Nervive

Status: Completed

Conditions: Normal Subject / Healthy Volunteers

Treatments: Device: magnetic facial nerve stimulation

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03487393

NRV_PI_01_15

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Vitalflow treatment

Experimental group

Description:

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%).

Treatment:

Device: magnetic facial nerve stimulation