Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Using needle electrolysis on the ear to treat headaches

Official title: Use of Infrared Thermography in the Measurement of Facial Blood Flow After the Application of Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear

Run by University of Alcala · NCT05662722 · Data updated 2026-11-12

This study is testing if a new treatment using tiny needles on the ear can help reduce headaches and improve symptoms for people who suffer from them.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Alcala
Academic / other
Locations1 site (Alcalá de Henares, Madrid)
StatusRecruiting
StartedMarch 22, 2022
Main results expectedSeptember 26, 2026
Study endsDecember 1, 2027
Registry record updatedMay 1, 2026
Trial IDNCT05662722 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults experiencing headaches at least once a month and exhibiting a 'cold nose' or 'cold patch' pattern.

Probably not a fit

Patients who do not show the 'cold nose' or 'cold patch' pattern, pregnant women, or those with certain facial conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of percutaneous needle electrolysis on the concha of the ear to treat headaches. The approach involves stimulating the auricular vagal nerve with galvanic current delivered through a needle electrode, aiming to modulate pain and inflammation associated with headaches. The study will measure outcomes using infrared thermography to assess changes in facial skin temperature, particularly looking for patterns indicative of sympathetic activity. Participants will be monitored for headache frequency and symptom relief throughout the intervention.

Why it matters

Potential benefit: If successful, this treatment could provide a novel, non-invasive option for patients suffering from various types of headaches.

How similar studies have gone: While the use of auricular stimulation for headache treatment has been explored, this specific approach using needle electrolysis is relatively novel and has not been widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Headache with a frequency of at least one monthly episode.
* Present the "cold nose" and/or "cold patch" pattern

Exclusion Criteria:

* 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's running

  • Physioterapy and Pain center research
    Alcalá de Henares, Madrid, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.