A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Children's Hospital of Orange County
Summary
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.
Description
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. Patient will be offered a Neurostim device. This device is placed on the outer ear through tiny needles. Since this is a randomized trial, patients may receive an active (experiment) or nonactive (control) Neurostim device. However, the nonactive control Neurostim device group will be given the option to receive an active device after the initial study procedures. The experiment group may be in this study up to 8 w…
Eligibility
- Age range
- 11–18 years
- Sex
- All
- Healthy volunteers
- No
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 ex…
Interventions
- Devicepercutaneous 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
- Devicepercutaneous 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.
- Devicepercutaneous 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
Location
- CHOC Children'sOrange, California