Not a traditional drug phase: percutaneous electrical nerve-field stimulation, PENFS for Post-Concussion Syndrome
This study wants 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.
Official registry: https://clinicaltrials.gov/study/NCT04978571 · Children's Hospital of Orange County · enrollment listed as 125
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are percutaneous electrical nerve-field stimulation, PENFS, percutaneous electrical nerve-field stimulation, PENFS (sham device), or percutaneous electrical nerve-field stimulation, PENFS (COVID active device). The registry lists allocation as randomized. This study wants to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms.
They plan to enroll about 125 people at Orange. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Interventions: percutaneous electrical nerve-field stimulation, PENFS, percutaneous electrical nerve-field stimulation, PENFS (sham device), percutaneous electrical nerve-field stimulation, PENFS (COVID active device)
Primary outcome (registry wording): Immediate Post-Concussion Assessment
Who it is for (from inclusion criteria)
- Ages 11 Years to 18 Years
- 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 the registry excludes
- Significant developmental delay
- Infection or severe dermatological condition of ear
- Implanted electrical device
- 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
Public study contact (from the registry)
Pari Mokhtari
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- CHOC Children's — Orange, California (recruiting)
FAQ about this NCT record
Is NCT04978571 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04978571?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04978571?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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