Currently submitted to: JMIR Research Protocols
Date Submitted: Apr 29, 2026
Open Peer Review Period: Apr 29, 2026 - Jun 24, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Transcutaneous Auricular Vagus Nerve Stimulation With Speech-Language Therapy for Post-Stroke Dysphagia in Elderly Adults: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Transcutaneous auricular vagus nerve stimulation (taVNS) is an emerging neuromodulation technique in rehabilitation research. While implanted vagus nerve stimulation is used clinically for epilepsy and treatment-resistant depression, its non-invasive form has mainly been explored in experimental settings, including physiotherapy and neuropsychiatry. Very few studies have investigated taVNS in speech-language pathology. However, given the vagus nerve's role in motor and sensory swallowing control, taVNS may offer a promising approach for dysphagia management - a frequent and severe complication in elderly stroke patients. Therefore, the development of an innovative protocol integrating taVNS appears pertinent in the context of swallowing rehabilitation.
Objective:
This protocol aims to evaluate the efficacy of taVNS combined with standard speech-language therapy for improving pharyngolaryngeal swallowing function and quality of life in elderly patients (≥70 years) with acute post-stroke dysphagia.
Methods:
This single-center, two-arm, randomized controlled clinical trial is conducted in a single-blind design. A total of 20 participants are expected to be enrolled. Eligible patients will be randomly allocated to receive either standard speech-language therapy combined with an inactive tVNS-E device, or standard speech-language therapy combined with non-invasive auricular vagus nerve stimulation via an active tVNS-E device. Both groups will undergo four rehabilitation sessions per week over three weeks. Clinical assessments (GUSS, SWAL-QoL, food trial) will be conducted at baseline T0 (inclusion) and at the end of the protocol at T3 (Week 3 – Day 4).
Results:
The study is currently in the participant recruitment phase. Recruitment began in April 2026. Baseline and post-test data collection is expected to continue until February 2028. Data analysis is planned for March 2028, and study results are expected to be published in April 2028.
Conclusions:
This will be the first randomized controlled trial evaluating taVNS for post-stroke dysphagia rehabilitation in patients aged ≥70 years. If effective, taVNS could provide a non-invasive adjunct to conventional speech-language therapy. Clinical Trial: ClinicalTrials.gov (NCT07428590)
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