Status:
COMPLETED
VitalFlow Healthy Volunteer Study
Lead Sponsor:
Nervive, Inc.
Collaborating Sponsors:
Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)
Conditions:
Normal Subject / Healthy Volunteers
Eligibility:
All Genders
20-40 years
Phase:
NA
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 ob...
Eligibility Criteria
Inclusion
- Healthy subjects
- Normal audiometry chart (Evaluated at the time of your inclusion).
- Normal neurological examination at time of inclusion.
Exclusion
- 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)
Key Trial Info
Start Date :
October 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03487393
Start Date
October 19 2015
End Date
January 8 2016
Last Update
April 4 2018
Active Locations (1)
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1
Centro Nacional de Investigación en Imagenología e Instrumentación Medica
Mexico City, Mexico City, Mexico, 09340