Testing a device for pain relief in children with post-concussion syndrome and COVID symptoms
A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
This study is testing a device that uses tiny needles on the ear to see if it can help children with post-concussion syndrome and COVID symptoms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Orange County Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT04978571 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 11-18 with a clinical diagnosis of Post-Concussion Syndrome or post-COVID symptoms lasting more than 3 months.
Not a fit: Patients with significant developmental delays, seizure disorders, or those with implanted electrical devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from pain and improve quality of life for children suffering from post-concussion and post-COVID symptoms.
How similar studies have performed: While the specific application of PENFS in this context is novel, similar approaches using electrical stimulation for pain relief have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orange, California
- CHOC Children's — Orange, California, United States (Recruiting)
Study contacts
- Study coordinator: Pari Mokhtari
- Email: pari.mokhtari@choc.org
- Phone: 714-509-8765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.