Transcutaneous auricular vagus nerve stimulation to improve breathing after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.