Ischemic StrokeNCT07894315

EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia

A study testing EEG Biofeedback-Guided taVNS and Conventional taVNS in people with Ischemic Stroke and Post-stroke Dysphagia, run by First Affiliated Hospital of Fujian Medical University at 6 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ischemic Stroke, Post-stroke Dysphagia, Swallowing Disorders
What is being tested?: EEG Biofeedback-Guided taVNS and Conventional taVNS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 6 sitesChina
Study dates: Nov 2026to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 80 years old, willing to participate and sign written informed consent.
First-ever acute ischemic stroke, or recurrent stroke with no prior history of dysphagia; diagnosis conforming to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.
Confirmed unilateral cerebral hemisphere (cortical or subcortical) infarction by cranial MRI or CT, in the subacute stage (2 weeks to 6 months post-stroke).
Objectively confirmed oropharyngeal dysphagia verified by videofluoroscopic swallowing study (VFSS); Gugging Swallowing Screen (KWST) >= grade 3.
Right-handed.
Mini-Mental State Examination (MMSE) score >= 22, conscious and stable, capable of understanding and cooperating with evaluations and treatments.
Basic motor imagery cognitive ability: assessed by the Kinesthetic and Visual Imagery Questionnaire (Short Version) (KVIQ-10) with a total score >= 25, and a mean item score >= 3 for the Kinesthetic subscale.

Who cannot join

History of other neurological diseases causing dysphagia (e.g., Parkinson's disease, motor neuron disease), structural abnormalities or surgical history of the oral cavity/pharynx/esophagus, or history of head and neck tumors or radiotherapy.
Presence of any metallic implants or electronic devices in the body (e.g., cardiac pacemaker, deep brain stimulator, cochlear implant, aneurysm clip).
Personal or family history of epilepsy.
Severe aphasia (especially sensory aphasia) or cognitive impairment preventing the understanding and execution of simple motor imagery or action commands.
Tracheotomy status.
Intolerance to videofluoroscopic swallowing study (VFSS) or prolonged electroencephalogram (EEG) examinations.

Show all 9Show fewer

Unstable vital signs, including severe infection, fever, uncontrolled arrhythmia, bleeding tendency, or severe medical conditions of the heart, liver, or kidneys.
Previous experimental treatments for post-stroke dysphagia (e.g., other forms of neuromodulation therapy) since the stroke onset.
Severe visual or hearing impairment preventing the clear viewing or hearing of screen-based motor imagery instructions.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhiyong Wang, M.D., Attending Physician contact

+86-13635298857

438769004@qq.com

City, postcode or hospital

6 sites in 1 country

China6 sites

Beijing Xiaotangshan Hospital
Beijing, 102200
Shasha Jin, M.D, +86 15201304230, jinshasha2007@126.com
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Zhiyong Wang, M.D, +86-13635298857, 438769004@qq.com
Jun Ni, Chief Physician, M.D.
Shaanxi Rehabilitation Hospital
Xi'an, Shaanxi, 710000
Shengli Ma, M.D, +86 13992924206, msl24206@163.com
Xi'an Central Hospital
Xi'an, Shaanxi, 710003
Zhengli Di, M.D, +86 13991161359, dizhengli@163.com
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, 363000
Chenfang Liang, M.D, +86 596 208 2030, 261992134@qq.com
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450013
Zhe Li, M.D, +86 371 6690 2132, Lizhe.1974@163.com

Other trials in China

About this study

Official title: Efficacy and Mechanism of EEG Feedback-Based Vagus Nerve Stimulation in the Rehabilitation of Post-Stroke Dysphagia

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:

Does EEG biofeedback-guided taVNS improve the ability to eat and drink by mouth?
What medical problems (adverse events) do participants have during the treatment?

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:

Receive standardized swallowing rehabilitation training for at least 30 minutes a day, 5 days a week for 2 weeks.
Practice swallowing imagery exercises with non-invasive surface EEG biofeedback monitoring while receiving gentle taVNS on the outer ear for 20 minutes a day, 5 days a week for 2 weeks.
Complete swallowing tests, questionnaires, and brain evaluations before treatment, after the 2-week treatment, and at Week 4 for follow-up.

Read the detailed description

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.

Conditions: Ischemic Stroke, Post-stroke Dysphagia, Swallowing Disorders
Being tested: EEG Biofeedback-Guided taVNS, Conventional taVNS
Keywords: Transcutaneous auricular vagus nerve stimulation, EEG biofeedback, Swallowing rehabilitation, Neuroplasticity
Medical subject headings: Ischemic Stroke, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EEG Biofeedback-Guided taVNSDevice
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 taVNSDevice
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).

Study groups in NCT07894315
Study group	Role	What they receive
EEG Biofeedback-Guided taVNS Group	Experimental	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. Receives: Device: EEG Biofeedback-Guided taVNS
Conventional taVNS Group	Active comparator	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). Receives: Device: Conventional taVNS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and 2 weeks post-treatment (Week 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2026Dec 2027

First posted26 Oct 2026
Study startNov 2026 (estimated)
Primary completionNov 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07894315
Sponsor's protocol ID: MRCTA, ECFAH of FMU[2026]488
Status last verified: Oct 2026
First submitted: 18 Oct 2026
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual participant data that underlie the results reported in the published article may be shared upon reasonable request.

Publications

Klemperer EM, Bunn JY, Palmer AM, Smith TT, Toll BA, Cummings KM, Carpenter MJ. E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study. Addiction. 2023 Jun;118(6):1161-1166. doi: 10.1111/add.16141. Epub 2023 Feb 9.
PubMed 36710461
Zou N, Zhou Q, Zhang Y, Xin C, Wang Y, Claire-Marie R, Rong P, Gao G, Li S. Transcutaneous auricular vagus nerve stimulation as a novel therapy connecting the central and peripheral systems: a review. Int J Surg. 2024 Aug 1;110(8):4993-5006. doi: 10.1097/JS9.0000000000001592.
PubMed 38729100
Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
PubMed 33894832
Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
PubMed 34746431

Interested in taking part?

Zhiyong Wang, M.D., Attending Physician

+86-13635298857

438769004@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Mechanism of EEG Feedback-Based Vagus Nerve Stimulation in the Rehabilitation of Post-Stroke Dysphagia
ClinicalTrials.gov ID: NCT07894315
Acronym / sponsor ID: MRCTA, ECFAH of FMU[2026]488
Conditions: Ischemic Stroke, Post-stroke Dysphagia, Swallowing Disorders
Keywords: Transcutaneous auricular vagus nerve stimulation, EEG biofeedback, Swallowing rehabilitation, Neuroplasticity
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
Study start: Nov 2026 (estimated)
Primary completion: Nov 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 26 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Does EEG biofeedback-guided taVNS improve the ability to eat and drink by mouth?
What medical problems (adverse events) do participants have during the treatment?

Participants will:

Receive standardized swallowing rehabilitation training for at least 30 minutes a day, 5 days a week for 2 weeks.
Practice swallowing imagery exercises with non-invasive surface EEG biofeedback monitoring while receiving gentle taVNS on the outer ear for 20 minutes a day, 5 days a week for 2 weeks.
Complete swallowing tests, questionnaires, and brain evaluations before treatment, after the 2-week treatment, and at Week 4 for follow-up.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EEG Biofeedback-Guided taVNS Group	Experimental	Device: EEG Biofeedback-Guided taVNSParticipants 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.
Conventional taVNS Group	Active comparator	Device: Conventional taVNSParticipants 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).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18 to 80 years old, willing to participate and sign written informed consent.
First-ever acute ischemic stroke, or recurrent stroke with no prior history of dysphagia; diagnosis conforming to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.
Confirmed unilateral cerebral hemisphere (cortical or subcortical) infarction by cranial MRI or CT, in the subacute stage (2 weeks to 6 months post-stroke).
Objectively confirmed oropharyngeal dysphagia verified by videofluoroscopic swallowing study (VFSS); Gugging Swallowing Screen (KWST) >= grade 3.
Right-handed.

Key exclusion criteria (9 listed)

History of other neurological diseases causing dysphagia (e.g., Parkinson's disease, motor neuron disease), structural abnormalities or surgical history of the oral cavity/pharynx/esophagus, or history of head and neck tumors or radiotherapy.
Presence of any metallic implants or electronic devices in the body (e.g., cardiac pacemaker, deep brain stimulator, cochlear implant, aneurysm clip).
Personal or family history of epilepsy.
Severe aphasia (especially sensory aphasia) or cognitive impairment preventing the understanding and execution of simple motor imagery or action commands.
Tracheotomy status.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EEG Biofeedback-Guided taVNSTranscutaneous 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).	Device	EEG Biofeedback-Guided taVNS Group
Conventional taVNSConventional 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).	Device	Conventional taVNS Group

Primary outcome

Functional Oral Intake Scale (FOIS) Score
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
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.

8 secondary outcomes

Penetration-Aspiration Scale (PAS) Score
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Functional Dysphagia Scale (FDS) Score
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Swallowing Quality of Life (SWAL-QOL) Questionnaire Score
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)
Mini Nutritional Assessment (MNA) Score
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)
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment)
Changes in Cortical Oscillations and Brain Network Connectivity using High-Density Electroencephalogram (EEG)
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)
Time frame: Baseline (Pre-treatment), Week 2 (Post-treatment)
Changes in Corticospinal Excitability using Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS-MEP)
Time frame: Baseline (Week 0) and 2 weeks post-treatment (Week 2)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Background: PubMed 36710461Klemperer EM, Bunn JY, Palmer AM, Smith TT, Toll BA, Cummings KM, Carpenter MJ. E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study. Addiction. 2023 Jun;118(6):1161-1166. doi: 10.1111/add.16141. Epub 2023 Feb 9.
Background: PubMed 38729100Zou N, Zhou Q, Zhang Y, Xin C, Wang Y, Claire-Marie R, Rong P, Gao G, Li S. Transcutaneous auricular vagus nerve stimulation as a novel therapy connecting the central and peripheral systems: a review. Int J Surg. 2024 Aug 1;110(8):4993-5006. doi: 10.1097/JS9.0000000000001592.
Background: PubMed 33894832Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
Background: PubMed 34746431Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in the published article may be shared upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Zhiyong Wang, M.D., Attending Physician contact

+86-13635298857

438769004@qq.com

Jun Ni, Chief Physician, M.D. principal investigator

First Affiliated Hospital of Fujian Medical University

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhiyong Wang, M.D., Attending Physician (+86-13635298857, 438769004@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Oral Intake Scale (FOIS) Score (time frame: Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07894315, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.