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PENFS for Post-Concussion Syndrome and COVID Long-Haul

This study is testing a device called percutaneous electrical nerve-field stimulation (PENFS) to see if it can help children aged 11-18 with Post-Concussion Syndrome (PCS) or ongoing symptoms after COVID-19 (COVID Long-Haul). PENFS is a device that delivers electrical stimulation to the outer ear. Researchers want to see if this device can improve symptoms like pain and other issues related to concussions or long-term COVID. You might receive an active PENFS device or a sham device (which looks the same but doesn't deliver stimulation). The study will measure improvements using assessments like the Immediate Post-Concussion Assessment, Post-Concussion Symptom Scale, and Balance Error Scoring Symptom after 8 weeks. The current recruitment status is unclear.

Study design
This is an interventional study with an unspecified phase, planning to enroll 125 participants. It is a randomized trial, meaning you may receive an active or non-active (sham) device.
What's involved
You would wear the device on your outer ear for 5 consecutive days each week, for 4 weeks. Study procedures include neurological tests (balance, computerized testing), cardiology tests (ECG, pupilometer), and parent/child questionnaires. You could be in the study for up to 8 or 12 weeks depending on your group.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms and balance will be measured at 8 weeks after starting the study.

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NCT04978571

Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

Recruiting
NAAges 11–18InterventionalTreatment
Children's Hospital of Orange County
~125 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:percutaneous electrical nerve-field stimulation, PENFSpercutaneous electrical nerve-field stimulation, PENFS (sham device)percutaneous electrical nerve-field stimulation, PENFS (COVID active device)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immediate Post-Concussion Assessment
Measured over 8 weeks
+3 more outcomes measured

Conditions

Post-Concussion Syndrome
COVID Long-Haul
COVID-19

Explore related trials

COVID-19 InfectionPostconcussion syndrome

Where it's being run

1 sites across 1 states
California1

Who to contact

Pari Mokhtari
[email protected]
714-509-8765
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Seizure disorders
Significant developmental delay
Infection or severe dermatological condition of ear
Bleeding disorders
Implanted electrical device
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.

What this trial measures

  • Immediate Post-Concussion Assessment8 weeks

    With the Immediate Post-Concussion Assessment, percentiles indicate functioning assessment after a concussion. Having a higher score on this assessment implies having a worse outcome assessment.

  • Post-Concussion Symptom Scale8 weeks

    Post Concussion Symptom Scale- a 22 item questionnaire, rated on a 0-6 scale. Having a higher score indicates having worse symptom assessment.

  • Balance Error Scoring Symptom8 weeks

    Balance Error Scoring Symptom- a balance test conducted in person. Patient is asked to do a 3 poses on the floor and 3 poses standing on a foam and asked to stand still. The amount of errors will be counted for the times the patient moves. The higher the errors, means patient does not have a well-balance.

  • COGNIGRAM10 weeks

    COGNIGRAM is a test prescribed by clinicians to measure cognitive function.