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
Verified date | March 2018 |
Source | Nervive, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.
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) |
Country | Name | City | State |
---|---|---|---|
Mexico | Centro Nacional de Investigación en Imagenología e Instrumentación Medica | Mexico City | Cdmx |
Lead Sponsor | Collaborator |
---|---|
Nervive, Inc. | Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M) |
Mexico,
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 |