Study of Auricular Percutaneous Electrical Nerve Field Stimulation PENFS for Children and Teens With Post-Concussion Syndrome and Post COVID-19 Symptoms

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.

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