Clinical Trial

Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear

Recruiting
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Summary
Headache is a very frequent symptom among the world population, the adult population with an active headache disorder are 46% for headache in general, 11% for migraine, 42% for tension-type headache and 3% for chronic daily headache. There are different therapeutic approaches for the improvement of headache. Transcutaneous stimulation of the auricular vagal nerve is being used for the treatment of headache due to the involvement of the vagus nerve in inflammation and pain modulation. On the other hand, galvanic current has shown a measurable effect by increasing parasympathetic activity. The objective of this clinical trial is to stimulate the auricular vagal nerve with galvanic current using a needle as an electrode that will be inserted into the concha of the ear. As a tool for measuring results, infrared thermography will be used to observe changes in facial skin temperature, since patients with high sympathetic activity present a characteristic pattern of "cold nose" and/or "cold patch". In addition, variables that record changes in autonomic activity such as skin conductance and heart rate variability will be collected.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-12-14; most recent amendment 2026-04-27.
Status change: Not Yet Recruiting → Recruiting 2023-03-22
Trial Details
NCT Number NCT05662722
Lead Sponsor University of Alcala
Conditions Headache
Enrollment 60 participants
Start Date 2022-03-22
Primary Completion 2026-09-26 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-01