An interventional study of EEG Biofeedback-Guided taVNS and Conventional taVNS in Ischemic Stroke, Post-stroke Dysphagia and Swallowing Disorders, sponsored by First Affiliated Hospital of Fujian Medical University. Not yet recruiting at 6 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by First Affiliated Hospital of Fujian Medical University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if electroencephalogram (EEG) biofeedback-guided transcutaneous auricular vagus nerve stimulation (taVNS) works to treat swallowing difficulties (dysphagia) in adults after a stroke. It will also learn about the safety of this rehabilitation method and how it helps the brain recover. The main questions it aims to answer are:
Researchers will compare EEG biofeedback-guided taVNS (where gentle electrical stimulation to the outer ear is paired with surface brainwave monitoring during swallowing exercises) to conventional taVNS (where electrical stimulation is given at fixed times) to see which method better improves swallowing function.
Participants will:
This multicenter, randomized, single-blind (outcomes assessor-blinded), parallel-group superiority study is designed to evaluate the therapeutic efficacy and neuroplasticity mechanisms of electroencephalogram (EEG) biofeedback-guided transcutaneous auricular vagus nerve stimulation (taVNS) in patients with subacute post-stroke dysphagia.
A total of 60 eligible participants will be recruited across 6 clinical centers in China and randomly assigned in a 1:1 ratio to either the EEG biofeedback-guided taVNS group or the conventional open-loop taVNS group using a central randomization system. Both cohorts will receive standard swallowing rehabilitation training combined with 20 minutes of taVNS intervention per session (frequency: 30 Hz, pulse width: 200 µs, 5 sessions per week for 2 weeks, 10 sessions in total). Stimulation electrodes will be placed on the left cymba conchae and cavum conchae. In the experimental group, non-invasive scalp EEG signals over the sensorimotor cortex are recorded via a biofeedback monitoring system to pair taVNS pulses with active motor imagery practice. The control group receives conventional taVNS at preset fixed intervals without biofeedback guidance.
Quality assurance and data management will be strictly maintained. Source data verification (SDV) will be performed by independent clinical research monitors (CRA). Data entry will utilize a double-entry mechanism or an electronic data capture (EDC) system with built-in logical validation rules to ensure accuracy and traceability, supported by a standardized query resolution workflow.
The sample size of 60 participants (30 per group) was determined to account for a 20% dropout rate, ensuring adequate statistical power for exploratory evaluation. The primary efficacy endpoint is the Functional Oral Intake Scale (FOIS) score, evaluated at baseline, post-treatment (Week 2), and follow-up (Week 4), alongside secondary clinical scales (PAS, FDS, SWAL-QOL, MNA) and multimodal neurophysiological/neuroimaging assessments (VFSS, fNIRS, high-density EEG, rs-fMRI, and TMS-MEP).
Statistical analysis will follow the intention-to-treat (ITT) principle using SPSS 26.0 and R 4.5.1. Longitudinal missing data will be primarily addressed using mixed-effects models for repeated measures (MMRM). Continuous secondary outcomes will be evaluated using analysis of covariance (ANCOVA), adjusting for baseline values and multicenter effects, with a two-sided significance level set at α = 0.05.
2,656 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →First Affiliated Hospital of Fujian Medical University is the lead sponsor of 96 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Participants will receive standardized swallowing rehabilitation training (at least 30 minutes per session, 5 sessions per week for 2 weeks, 10 sessions in total) combined with EEG biofeedback-guided transcutaneous auricular vagus nerve stimulation (taVNS). During taVNS intervention (30 Hz, 200 µs, 20 minutes per session, 5 sessions per week for 2 weeks), participants perform swallowing motor imagery tasks while non-invasive surface EEG biofeedback pairs the electrical stimulation with active rehabilitation training.
Device: EEG Biofeedback-Guided taVNS
Participants will receive standardized swallowing rehabilitation training (at least 30 minutes per session, 5 sessions per week for 2 weeks, 10 sessions in total) combined with conventional transcutaneous auricular vagus nerve stimulation (taVNS). Participants also perform swallowing imagery tasks during the session, but conventional taVNS pulses are delivered at preset fixed intervals without biofeedback guidance (30 Hz, 200 µs, 20 minutes per session, 5 sessions per week for 2 weeks).
Device: Conventional taVNS
Transcutaneous auricular vagus nerve stimulation guided by non-invasive surface EEG biofeedback during swallowing imagery exercises. Stimulation electrodes are placed at the left cymba conchae and cavum conchae. Parameters: frequency 30 Hz, pulse width 200 µs, 20 minutes per session, 5 sessions per week for 2 weeks (10 sessions in total).
Conventional transcutaneous auricular vagus nerve stimulation delivered at preset fixed intervals without biofeedback guidance. Stimulation electrodes are placed at the left cymba conchae and cavum conchae. Parameters: frequency 30 Hz, pulse width 200 µs, 20 minutes per session, 5 sessions per week for 2 weeks (10 sessions in total).
Functional Oral Intake Scale (FOIS) Score
The Functional Oral Intake Scale (FOIS) is a clinician-rated assessment tool used to evaluate the functional level of oral intake of food and liquid in dysphagia patients. It assesses the patient's actual dietary intake and dependence on tube feeding. Unit of Measure: Units on a Scale. Score range: 1 to 7. A score of 1 indicates nothing by mouth (NPO), and a score of 7 indicates total oral diet with no restrictions. Therefore, higher scores indicate better functional oral intake and improved swallowing ability.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Penetration-Aspiration Scale (PAS) Score
The Penetration-Aspiration Scale (PAS) is a standardized scoring system used during Video fluoroscopic Swallowing Study (VFSS) to objectively assess airway protection. It evaluates the depth to which material passes into the airway and whether the patient is able to expel it. Unit of Measure: Units on a Scale. Score range: 1 to 8. A score of 1 indicates material does not enter the airway, and a score of 8 indicates material enters the airway, passes below the vocal folds, and no effort is made to eject it. Therefore, higher scores indicate worse swallowing safety and a greater severity of aspiration.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Functional Dysphagia Scale (FDS) Score
The Functional Dysphagia Scale (FDS) is a semi-quantitative assessment tool based on Video fluoroscopic Swallowing Study (VFSS) findings. It is used to quantify the severity of swallowing dysfunction by evaluating both the oral phase and the pharyngeal phase. Unit of Measure: Units on a Scale. Score range: 0 to 100. A score of 0 indicates normal swallowing function, and a score of 100 indicates the most severe swallowing impairment. Therefore, higher scores indicate worse swallowing function.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Swallowing Quality of Life (SWAL-QOL) Questionnaire Score
The Swallowing Quality of Life (SWAL-QOL) questionnaire is a patient-reported outcome measure used to comprehensively assess the multi-dimensional impact of dysphagia on physical, social, and psychological well-being. Unit of Measure: Units on a Scale. Score range: 0 to 100 for the total score. A score of 0 represents the worst possible quality of life, and a score of 100 represents the best possible quality of life. Therefore, higher scores indicate a better quality of life.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Mini Nutritional Assessment (MNA) Score
The Mini Nutritional Assessment (MNA) is a validated screening and assessment tool used to evaluate the nutritional status and identify the risk of malnutrition in elderly and post-stroke patients. Unit of Measure: Units on a Scale. Score range: 0 to 30. A score of 24-30 indicates normal nutritional status, and a score of less than 17 indicates malnutrition. Therefore, higher scores indicate better nutritional status.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Changes in Cerebral Cortex Hemodynamic Responses using Functional Near-Infrared Spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique used to continuously monitor changes in the concentration of oxygenated hemoglobin (HbO2) in the sensorimotor and swallowing-related cortical areas during swallowing tasks. This assesses task-related cortical activation and functional cortical reorganization. Unit of Measure: Micro Molar (μmol/L). Higher HbO2 concentration changes indicate greater cortical activation and enhanced neural plasticity in swallowing networks.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment)
Changes in Cortical Oscillations and Brain Network Connectivity using High-Density Electroencephalogram (EEG)
High-density electroencephalogram (EEG) is a neurophysiological measurement used to evaluate the absolute and relative power spectral density across different frequency bands (Delta, Theta, Alpha, Beta, and Gamma) and calculates functional connectivity metrics between key swallowing-related brain networks during resting state. Unit of Measure: Coherence value (Units on a Scale). Higher functional connectivity coefficients (coherence values) indicate stronger inter-regional brain coupling and improved neural network synchronization.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment)
Changes in Whole-Brain Resting-State Functional Connectivity using Resting-State Functional Magnetic Resonance Imaging (rs-fMRI)
Resting-state functional magnetic resonance imaging (rs-fMRI) is an advanced neuroimaging modality used to detect spontaneous low-frequency fluctuations. It calculates the amplitude of low-frequency fluctuations (ALFF) and seed-based functional connectivity specifically between swallowing network nodes and brainstem/cortex regions. Unit of Measure: Z-score. Higher Z-scores indicate enhanced baseline neural activity, stronger functional connectivity, and significant neural network remodeling.
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment)
Changes in Corticospinal Excitability using Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS-MEP)
Transcranial magnetic stimulation (TMS) is used to elicit motor evoked potentials (MEP) recorded from swallowing-related musculature (e.g., mylohyoid muscle). This technique evaluates the functional integrity and excitability of the corticobulbar and corticospinal motor pathways targeting the swallowing muscles. Unit of Measure: Millivolts (mV). A higher peak-to-peak MEP amplitude indicates increased excitability of the motor pathways and positive neural remodeling in the central nervous system.
Time frame: Baseline (Week 0) and 2 weeks post-treatment (Week 2)
Plan to share: Yes — Deidentified individual participant data that underlie the results reported in the published article may be shared upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months following article publication.
Access criteria: Proposals directed to the corresponding author will be evaluated and granted at the discretion of the study investigators based on feasibility and scientific validity.
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First Affiliated Hospital of Fujian Medical University