Actively Recruiting
A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Children With Post Concussion Syndrome and Post COVID-19 Symptoms
Led by Children's Hospital of Orange County · Updated on 2026-03-18
125
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Orange County
Lead Sponsor
I
Innovative Health Solutions
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS), a device placed on the outer ear using tiny needles, on children aged 11 to 18 years who have pain and symptoms from Post-Concussion Syndrome or post COVID-19. The study aims to see if PENFS improves functioning in these children. It is an interventional trial with randomized and non-randomized groups. Participants will receive either an active PENFS device or a sham (nonactive) device worn on the ear for 5 consecutive days each week. In the post-concussion group, the active group wears the device weekly for 4 weeks, while the sham group wears it for 4 weeks then can switch to active for an additional 4 weeks. The COVID-19 group receives active devices for 6 weeks without randomization. The device is removed on the 6th day after each 5-day wear period. During the study, children will undergo neurological tests including balance tests and computerized assessments, heart rate variability monitoring, pupil measurements, and complete questionnaires with their parents. The COVID group will have cognitive function testing called Cognigram and questionnaires over 10 weeks. Researchers will measure post-concussion symptoms, cognitive function, balance errors, and other health and symptom scales to assess outcomes. The study may last up to 12 weeks depending on the group, with close monitoring throughout.
CONDITIONS
Brief Title
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Post-Concussion Syndrome
- Post-Concussion Symptoms for at least 3 months without other explanation
- English or Spanish-speaking families
- Age 11 to 18 years
- Post COVID-19 symptoms lasting more than 3 months without other explanation
- Ability to attend Friday appointments for device placements
You will not qualify if you...
- Seizure disorders
- Significant developmental delay
- Infection or severe dermatological condition of the ear
- Bleeding disorders
- Implanted electrical device
- Inability to attend Friday appointments for Neurostim placements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 12 weeks depending on group assignment
Participants receive percutaneous electrical nerve-field stimulation devices worn weekly. Devices are placed on the outer ear with tiny needles and worn for 5 consecutive days each week.
Weekly visits for device placement up to 6 weeks
Duration - 1 week
Participants complete questionnaires and neurological testing after device placements to assess symptom changes and cognitive function.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
CHOC Children's
Orange, California, United States, 92868
Actively Recruiting
Research Team
P
Pari Mokhtari
J
Jamie Janchoi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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