RECRUITINGINTERVENTIONAL

Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

About This Trial

The purpose of this study is to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms. An additional purpose of this study is to demonstrate that PENFS improves functioning in children with post Covid-19 symptoms.

Who May Be Eligible (Plain English)

Concussion: Who May Qualify: - Clinical diagnosis of Post-Concussion Syndrome - Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms - English and Spanish-speaking families Who Should NOT Join This Trial: - Seizure disorders - Significant developmental delay - Infection or severe dermatological condition of ear - Bleeding disorders - Implanted electrical device COVID: Inclusion Criteria - Child is in between the ages 11-18 - Child is present at CHOC Neurology clinic post covid-19 symptoms of more than 3 months duration along with lack of other explanation for their symptoms - English-speaking and Spanish-speaking families You cannot participate in this study if you meet the following Who Should NOT Join This Trial: - Children with significant developmental delay, infection or severe dermatological condition of ear, bleeding disorders, or having any implanted electrical device will be excluded. - Are not able to attend Friday appointments for the Neurostim placements. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Concussion: Inclusion Criteria: * Clinical diagnosis of Post-Concussion Syndrome * Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms * English and Spanish-speaking families Exclusion Criteria: * Seizure disorders * Significant developmental delay * Infection or severe dermatological condition of ear * Bleeding disorders * Implanted electrical device COVID: Inclusion Criteria * Child is in between the ages 11-18 * Child is present at CHOC Neurology clinic post covid-19 symptoms of more than 3 months duration along with lack of other explanation for their symptoms * English-speaking and Spanish-speaking families You cannot participate in this study if you meet the following exclusion criteria: * Children with significant developmental delay, infection or severe dermatological condition of ear, bleeding disorders, or having any implanted electrical device will be excluded. * Are not able to attend Friday appointments for the Neurostim placements.

Treatments Being Tested

DEVICE

percutaneous electrical nerve-field stimulation, PENFS

A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear

DEVICE

percutaneous electrical nerve-field stimulation, PENFS (sham device)

A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear. The sham device will not deliver field stimulation to the ear.

DEVICE

percutaneous electrical nerve-field stimulation, PENFS (COVID active device)

A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear

Locations (1)

CHOC Children's

Orange, California, United States