Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Headache
In brief
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.
Key facts
- Study ID
- NCT05662722
- Run by
- University of Alcala
- People needed
- 60
- Starts
- 2022-03-22
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Headache with a frequency of at least one monthly episode.
- Present the "cold nose" and/or "cold patch" pattern
You may not qualify if…
- Do not present a "cold nose" and/or "cold patch" pattern
- Pregnant women
- Subjects with facial alterations that may affect facial vascularization (sinusitis, allergies...)
- Patients with belonephobia or allergy to metals or any material used in the procedure.
Where it is running
- Physioterapy and Pain center research — Alcalá de Henares, Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.