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)
Children's Hospital of Orange County
125 participants
Feb 1, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Concussion:
- 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
- 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
Exclusion Criteria8
- Seizure disorders
- Significant developmental delay
- Infection or severe dermatological condition of ear
- Bleeding disorders
- Implanted electrical device
- COVID:
- 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.
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Interventions
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
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.
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04978571