Recruiting

PENFS

Sponsor:

Children's Hospital of Orange County

Code:

NCT04978571

Conditions

Post-Concussion Syndrome

COVID Long-Haul

COVID-19

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

percutaneous electrical nerve-field stimulation, PENFS

percutaneous electrical nerve-field stimulation, PENFS (sham device)

percutaneous electrical nerve-field stimulation, PENFS (COVID active device)

Study Details

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.

Conditions

Post-Concussion Syndrome

COVID Long-Haul

COVID-19

Study ID

NCT04978571

Start date

Feb 1, 2021

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Neurostim Device

Patients in this group will receive the active devices for the initial 4 study weeks.

sham comparator: Sham Neurostim Device

Patients in this group will receive the sham devices for the initial 4 study weeks. However, they will be offered the 4 active devices after.

experimental: COVID Active Neurostim Device

Patients in this group will receive the active devices for the 6 study weeks.

Interventions

percutaneous electrical nerve-field stimulation, PENFS

A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear

percutaneous electrical nerve-field stimulation, PENFS (sham device)

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.

percutaneous electrical nerve-field stimulation, PENFS (COVID active device)

A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear

Primary outcome measure

  • Immediate Post-Concussion Assessment [ Time Frame: 8 weeks ]
  • Post-Concussion Symptom Scale [ Time Frame: 8 weeks ]
  • Balance Error Scoring Symptom [ Time Frame: 8 weeks ]
  • COGNIGRAM [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Pari Mokhtari

714-509-8765pari.mokhtari@choc.org

Jamie Janchoi

714-509-8765jamie.janchoi@choc.org

Locations

CHOC Children's

Recruiting

Orange, California, United States, 92868

Contacts

Pari Mokhtari

pari.mokhtari@choc.org

More Information

Sponsor

Children's Hospital of Orange County

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Orange County on 2026-03-18.