Transcutaneous auricular vagus nerve stimulation to improve breathing after stroke
Effect of TAVNS Application on Respiratory Functions in Stroke Patients
This study will try transcutaneous auricular vagus nerve stimulation plus standard physiotherapy to see if it strengthens breathing muscles in people 1–3 years after a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Fenerbahce University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06793800 on ClinicalTrials.gov |
What this trial studies
Fifty chronic stroke patients (1–3 years post-stroke) were randomized to receive either active transcutaneous auricular vagus nerve stimulation (TAVSS) plus conventional physiotherapy or sham TAVSS plus the same physiotherapy. Treatments were delivered three times weekly for a total of 10 sessions, with active TAVSS applied for 20 minutes using a biphasic asymmetric waveform. Outcome measures included respiratory parameters such as vital capacity, maximum inspiratory and expiratory pressures, expiratory reserve volume, and chest circumference, collected before and after the intervention. The control arm received identical physiotherapy and sham stimulation to isolate the effect of TAVSS on respiratory function.
Who should consider this trial
Good fit: Ideal candidates are first-time ischemic or hemorrhagic stroke survivors aged 40–80 who are 1–3 years post-stroke, can follow simple verbal instructions, have MMSE ≥24, low spasticity (Modified Ashworth ≤2), and no cardiopulmonary disease.
Not a fit: Patients with active ear wounds, metal implants in the skull, chronic pulmonary or cardiac disease, resting heart rate under 60 bpm, significant cognitive or communication impairment, or high spasticity are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could improve respiratory muscle strength and breathing capacity after stroke, potentially reducing aspiration risk and supporting better rehabilitation outcomes.
How similar studies have performed: Noninvasive auricular vagus nerve stimulation has shown preliminary promise for autonomic and motor outcomes in prior pilot studies, but respiratory-specific evidence remains limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being a chronic stroke patient with an ischemic or hemorrhagic stroke diagnosis made 1-3 years ago * Having been diagnosed with stroke for the first time * Ability to understand and follow simple verbal instructions * Being between the ages of 40 and 80 * No conditions affecting perioral muscles, such as facial paralysis or swallowing disorders * No visual, auditory, or communication problems * No cardiopulmonary disorders * No additional neurological, cardiovascular, orthopedic, or similar conditions causing balance problems * Mini Mental State Examination (MMSE) score ≥24 * No surgical operations or Botox applications in the last 6 months * Scoring 2 or below on the Modified Ashworth Scale Exclusion Criteria: * Presence of infection, ulcer, or scar on the auricle * Metallic implants in the skull, hypersensitivity, injury, or inflammation inside the ear * Chronic pulmonary and/or cardiac diseases * Resting heart rate below 60 beats per minute * Devices such as pacemakers or cochlear implants * Uncontrolled hypertension * Chronic obstructive pulmonary disease (COPD) or asthma unrelated to stroke * History of surgical operation or Botox application within the last 6 months * Presence of aphasia, apraxia, or neglect syndrome * History of 2 or more strokes (SVO) * Comorbid conditions affecting respiratory functions (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, contractures, deformities after fractures, active upper or lower respiratory infections, etc.) * Lack of cooperation
Where this trial is running
Istanbul
- Mediworld Medical Center Physical Therapy and Rehabilitation Department — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Burcu AKKURT, Ph.D.
- Email: burcu.akkurt@fbu.edu.tr
- Phone: +9005536046713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.