NCT04978571 Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
| NCT ID | NCT04978571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Orange County |
| Condition | Post-Concussion Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2021-02-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04978571 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, studying Post-Concussion Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04978571 currently recruiting?
Yes, NCT04978571 is actively recruiting participants. Contact the research team at pari.mokhtari@choc.org for enrollment information.
Where is the NCT04978571 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT04978571 clinical trial?
NCT04978571 is sponsored by Children's Hospital of Orange County. The trial plans to enroll 125 participants.