stroke
Conditions
Interventions
True Stimulation Group:True taVNS stimulation combined with guideline-based conventional dysphagia rehabilitation, with the intensity set at the maximum tolerable level for the subjects.
Sham Stimulation Group:Sham taVNS stimulation combined with conventional dysphagia rehabilitation based on guidelines, the stimulation intensity for the first 30 seconds is the maximum tolerable value
Sponsors
The Eighth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with stroke based on cranial CT or MRI imaging; 2. Stroke in the subacute phase, with a course of >7 days and <=6 months; 3. Aged 30-80 years; 4. Diagnosed with swallowing dysfunction via VFSS or FEES, with an FOIS score <7; 5. Conscious and able to cooperate with study-related assessments or procedures; 6. Voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of skin damage or skin lesions at the stimulation site of the left ear (such as sunburn, cuts, open abscesses, dermatitis, ulcers, etc.); 2. Obvious sensory impairment in the ear; 3. Presence of other diseases that may affect swallowing function, such as head and neck cancer, Parkinson's disease, Alzheimer's disease, etc.; 4. Active epilepsy or having had a seizure within the past 6 months, or other severe neurological diseases judged as unsuitable for neuroregulation intervention; 5. Presence of implanted electrical stimulation or neuroregulation devices in the body (such as invasive vagus nerve stimulation, deep brain stimulation, spinal cord stimulators), cardiac pacemaker/implantable cardioverter defibrillator, or other electronic implants that may cause electrical interference (such as cochlear implants); 6. Severe cardiac or other organ dysfunction, or other life-threatening systemic diseases, or currently in a clinically unstable period (for example, recent severe infection, respiratory failure requiring mechanical ventilation, circulatory instability, etc.); 7. Progressive stage of stroke; 8. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Oral Intake Scale, FOIS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rosenbek penetration-aspiration scale, PAS;dysphagia outcome and severity scale, DOSS;modified Mann assessment of swallowing ability, mMASA; | — |
Countries
China
Contacts
Public ContactShaofeng Zhao
The Eighth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed