Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorChildren's Hospital of Orange County
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Seizure disorders
Significant developmental delay
Infection or severe dermatological condition of ear
Bleeding disorders
Trial design
Treatments tested in this trial
- percutaneous electrical nerve-field stimulation, PENFS
- percutaneous electrical nerve-field stimulation, PENFS (sham device)
- percutaneous electrical nerve-field stimulation, PENFS (COVID active device)
Treatment groups
125 Participants
are divided into 3 treatment groupsSponsors and collaborators
Children's Hospital of Orange County
Lead sponsor
Innovative Health Solutions
Collaborator
Source ClinicalTrials.gov