Efficacy of Transcutaneous Auricular Trigeminal Nerve Stimulation in Migraine: A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial

Background: Migraine is a leading cause of disability worldwide. Transcutaneous auricular trigeminal nerve stimulation (taTNS) has emerged as a non-invasive neuromodulation approach targeting trigeminal pathways involved in pain modulation. Objective: To investigate the effects of taTNS on migraine pain intensity, sleep quality, disability, and Heart Rate Variability (HRV) in patients with migraine. Materials and Methods: This randomized, participant- and assessor-blind, sham-controlled trial included 102 participants who received taTNS (n = 51) or sham taTNS (n = 51). Active taTNS was administered bilaterally at 60 Hz, 250 μs, and up to 16 mA for 20 min, three times weekly for 12 weeks; sham stimulation used identical electrode placement at 0 mA. The primary outcome measures were migraine pain intensity (VAS), migraine-related disability (MIDAS) and sleep quality (PSQI); secondary outcomes included HRV, assessed using the standard deviation of normal-to-normal intervals (SDNN) and root mean square of successive differences (RMSSD). Results: At post-intervention, VAS and MIDAS scores were significantly lower in the taTNS group than in the sham-taTNS group (both p < 0.001), whereas PSQI scores did not differ significantly between groups (p = 0.870). RMSSD was significantly higher in the taTNS group than in the sham-taTNS group (p = 0.013), whereas the between-group difference in SDNN was not statistically significant (p = 0.187). Conclusions: Compared with sham stimulation, taTNS was associated with greater reductions in migraine pain intensity and migraine-related disability, but no significant between-group difference was observed in sleep quality.