Transcutaneous auricular vagus nerve stimulation in drug-resistant epilepsy: A randomized, sham-controlled crossover trial with exploratory EEG and MRI response phenotyping.

Active ear stimulation did not reduce seizures more than the sham condition in this small, carefully blinded pilot. Exploratory EEG and MRI patterns may help researchers study why responses differ, but they do not yet identify who will benefit.

Hong SJ, Yang SY, Bok EK, Lee JC, Kim Y, Min K, Shon YM.
Epilepsia open · Publication date: 2026-10-06
Added to site: 2026-10-09
DOI: 10.1002/epi4.70354

Published October 6, 2026. Added to Neurofeedback.com October 9, 2026.

Modalities

Transcutaneous auricular vagus nerve stimulation, EEG

Clinical focus

Drug-resistant focal epilepsy, Exploratory response phenotyping

Population

People with drug-resistant focal epilepsy

Sample

14 randomized participants

Intervention / method

Eight weeks of active taVNS and eight weeks of sham stimulation in randomized sequence, separated by a four-week washout; resting-state EEG at baseline and protocol end with exploratory structural MRI comparisons

Comparator

Sham auricular stimulation within participants

Clinician summary

Mean seizure-reduction ratios were 46.26% during active stimulation and 48.62% during sham, for a within-subject difference of -2.37 percentage points (p=0.604). Greater occipital and frontal beta attenuation correlated with active-specific benefit after false-discovery adjustment, while MRI responder comparisons were uncorrected and exploratory.

How to interpret the findings

Only 14 participants were studied at one center, the primary efficacy comparison was null, sham response was substantial and the imaging analyses were exploratory. MRI group comparisons were uncorrected, biomarker associations do not establish predictive validity, and the short phases do not establish durable benefit or safety.

Equipment and disclosures

The study used the allears taVNS device manufactured by TODOC Co., Ltd.; this attribution is retained because it is disclosed by the source and is not an endorsement.

Supported by Korean government ICT and National Research Foundation grants and Samsung Medical Center's Future Medicine 2030 Project. Author Kyousik Min is an employee of TODOC Co., Ltd., manufacturer of the study device; the remaining authors declared no conflicts.

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