Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Poststroke Dysphagia: Protocol for a Randomized, Sham-Controlled Clinical Trial.
Gao L, Li J, et al. • JMIR research protocols • 2026
This protocol describes a prospective, randomized, double-blind, sham-controlled trial of 40 patients with poststroke dysphagia that aims to validate the efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) and elucidate its underlying mechanisms. No efficacy results are reported.
Key Findings
Methods
The paper is a trial protocol and reports no efficacy or mechanism results; it describes a planned prospective, randomized, double-blind, sham-controlled trial of taVNS for poststroke dysphagia.
A total of 40 patients with PSD will be enrolled and randomly allocated to a taVNS group or a sham taVNS group.
Both groups will receive conventional swallowing rehabilitation therapy as the baseline intervention.
The stated aim is to validate taVNS efficacy for PSD and to elucidate its underlying mechanisms.
Methods
The taVNS intervention is planned as bilateral stimulation of the cymba conchae and cavum conchae, while the sham group receives stimulation at auricular regions not innervated by the vagus nerve.
The stimulated sites correspond to the 'Heart' and 'Kidney' auricular acupoints, selected according to traditional Chinese medicine theory.
The sham taVNS group will be stimulated at regions of the auricle not innervated by the vagus nerve.
The intervention period is 2 weeks.
Methods
The primary outcome is the Penetration-Aspiration Scale score.
Outcomes will be evaluated at baseline and after the 2-week intervention period.
Methods
Secondary outcomes include a pharyngeal residue rating, ultrasonographic measures of hyoid movement, and neurophysiological measures of suprahyoid muscle motor-evoked potentials.
The Yale Pharyngeal Residue Severity Rating Scale will be used.
Hyoid bone displacement and hyoid-thyroid approximation distance will be assessed via B-mode ultrasonography.
Motor-evoked potentials of the suprahyoid muscles will be elicited by transcranial magnetic stimulation, to address mechanisms.
Background
The study timeline: funded January 2025, with recruitment and data collection starting March 2025 and projected to end October 2026.
Primary results are expected to be submitted for publication in winter 2026.
The paper notes that optimal PSD treatment remains elusive and that taVNS requires validation in rigorously designed trials.
What This Means
This paper describes the plan for a clinical trial rather than reporting results. The trial will test whether a gentle electrical stimulation of the outer ear, called transcutaneous auricular vagus nerve stimulation (taVNS), can help people who have trouble swallowing after a stroke. Swallowing problems are common after stroke, and the authors note that the best treatment is still unclear.
The study plans to enroll 40 patients, who will be randomly assigned to real ear stimulation or a sham version applied to ear areas not served by the vagus nerve. Neither group will know which they received, and both will also get standard swallowing rehabilitation for 2 weeks. Researchers will measure swallowing safety with a standard scale, check for leftover food in the throat, use ultrasound to measure movement of throat structures, and use magnetic brain stimulation to measure signals to swallowing muscles, to try to understand how the treatment works.
Because no results are yet available, this research cannot say whether taVNS works. The trial is expected to finish recruiting by October 2026, and its findings could help show whether this noninvasive approach is a useful option for stroke survivors with swallowing difficulties.
Gao L, Li J, Xie M, Xu C, Zhang C, Kuang W, et al.. (2026). Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Poststroke Dysphagia: Protocol for a Randomized, Sham-Controlled Clinical Trial.. JMIR research protocols. https://doi.org/10.2196/95182