NCT07894315Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Efficacy and Mechanism of EEG Feedback-Based Vagus Nerve Stimulation in the Rehabilitation of Post-Stroke Dysphagia
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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: 1. Does EEG biofeedback-guided taVNS improve the ability to eat and drink by mouth? 2. 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: 1. Receive standardized swallowing rehabilitation training for at least 30 minutes a day, 5 days a week for 2 weeks. 2. 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. 3. Complete swallowing tests, questionnaires, and brain evaluations before treatment, after the 2-week treatment, and at Week 4 for follow-up.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Diseases
- Stroke
- NCT number
- NCT07894315
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Nov 2026 to the primary completion date, Nov 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous experimental treatments for post-stroke dysphagia (e.g., other forms of neuromodulation therapy) since the stroke onset.
Other illness
- 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.
- Unstable vital signs, including severe infection, fever, uncontrolled arrhythmia, bleeding tendency, or severe medical conditions of the heart, liver, or kidneys.
- Severe visual or hearing impairment preventing the clear viewing or hearing of screen-based motor imagery instructions.
Other
- Tracheotomy status.
- Intolerance to videofluoroscopic swallowing study (VFSS) or prolonged electroencephalogram (EEG) examinations.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Xiaotangshan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Shaanxi Rehabilitation Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xi'an Central Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Zhangzhou Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| The Fifth Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.