Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine

Summary

This randomized, sham-controlled, and double-blind clinical study aims to investigate the effects of transcutaneous auricular trigeminal nerve stimulation (taTNS) on intensity of headache, sleep quality, level of disability, and Heart rate variability (HRV) in patients with migraine.

The inclusion criteria were: (1) being aged 18-45 years, (2) being literate in Turkish, (3) having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders, (4) having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months. The exclusion criteria were: (1) being pregnant or breastfeeding; (2) regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month; (3) pacemaker implantation; (4) a history of addiction, syncope or abnormal ECG findings; (5) a history of intracranial haemorrhage or significant head trauma; (6) a diagnosis of epilepsy, severe anxiety or depression; (7) other types of headaches, including paresthesia or medication-overuse headaches; and (8) cognitive, visual, or auditory problems that would prevent participation in the study.

The TaTNS was applied to the intervention and control (sham) groups by a physiotherapist (AP). The treatment session lasted 20 minutes and will apply three days a week for 12 weeks.

The physical (age, gender, height, body weight), sociodemographic (marital status, education level), and clinical characteristics (chronic diseases, medications used, age of migraine onset, migraine frequency in the last month, migraine treatment history) of participants will be recorded.

Primary outcome measurement: Migraine headache intensity (VAS), disability level (Migraine Disability Assessment Scale \[MIDAS\]), sleep quality (Pittsburgh Sleep Quality Index \[PSQI\]), Secondary outcome measurement: Heart rate variability (HRV) (Polar H7 device) will be assessed.

All calculations will be performed using 5-minute Polar H7 recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.

Conditions

• Migraine

Interventions

DEVICE

Transcutaneous Auricular Trigeminal Nerve Stimulation

Transcutaneous Auricular Trigeminal Nerve Stimulation TaTNS stimulation is applied using a dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) with clip-on bipolar electrodes placed on the upper anterior part of the auricle. This region is innervated by the trigeminal nerve via the auriculotemporal nerve. Electrode gel is also used to facilitate electrical conductivity. Bilateral ear stimulation protocols are as follows: Two-phase rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity maximum 16 mA.

OTHER

Sham (No Treatment)

The sham-TaTNS application will performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application, but stimulation will applied at a very low intensity (below the sensory threshold, 1 mA) that would not produce a neuromodulatory effect, or only a brief stimulation was applied at the beginning to create a temporary sensation on the skin. This method provides an experience similar to the active application in terms of participants' perception of stimulation, but does not create effective physiological stimulation in the trigeminal nerve. The sham group will receive a frequency of 1 Hz and a current intensity of up to 1 mA

Sponsors & Collaborators

• Ordu University

  lead OTHER

Principal Investigators

• SEMİHA YENİŞEHİR · Ordu University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2026-04-01

Completion

2026-06-15