Testing a device for pain relief in children with post-concussion syndrome and COVID symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in children suffering from Post-Concussion Syndrome and post-COVID-19 symptoms. Participants will receive either an active or a nonactive Neurostim device, which is applied to the outer ear through tiny needles. The study involves neurological and cardiological assessments, and participants may be involved for up to 12 weeks depending on their group assignment. The aim is to determine if this treatment can alleviate symptoms and improve functioning in affected children.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHOC Children's
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Pari Mokhtari
• Email: pari.mokhtari@choc.org
• Phone: 714-509-8765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.