Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine

The participants with migraine headache will be randomly assigned to the two groups (TaTNS and sham TaTNS) in equal numbers using software (https://www.randomizer.org/). The TaTNS will be applied to the intervention and control (sham) groups by a physiotherapist (AP). The intervention will be applied three days a week for 12 weeks, with 20 minutes session duration. A dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) will be used for stimulation. In both groups, clip-on bipolar electrodes were placed on the upper-anterior part of the auricle. The bilateral auricular stimulation protocols as follows: Biphasic rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity increased to a maximum of 16 mA. The sham-TaTNS application was performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application. 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 received a frequency of 0 Hz and a current intensity of 0 mA. To assess the success rate of the blinding technique, at the end of the treatment period, each participant was asked to guess which treatment group they belonged to. Additionally, level of confidence in their guesses regarding the groups they belonged to was assessed using the Visual Analog Scale (VAS) (0-10 cm).