VitalFlow Healthy Volunteer Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-19

Study Completion Date

2016-01-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.

NCT04779814

Epilepsy

ACTIVE_NOT_RECRUITING

Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

NCT03537469

Electromagnetic Fields Neuronal Plasticity Transcranial Magnetic Stimulation

COMPLETED EARLY_PHASE1

Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders

NCT05926739

Musculoskeletal Disorder

COMPLETED NA

Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG

NCT06575413

Refractory Epilepsy Consciousness, Loss of

COMPLETED NA

Quantification and Repeatability of Magnetic Stimulation

NCT05302752

Healthy

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Subject / Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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%).

Group Type EXPERIMENTAL

magnetic facial nerve stimulation

Intervention Type DEVICE

Magnetic stimulation of facial nerve.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

magnetic facial nerve stimulation

Magnetic stimulation of facial nerve.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes