Transcutaneous auricular vagus nerve stimulation for people with disorders of consciousness

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

This interventional protocol applies noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) to patients with disorders of consciousness after severe brain injury. It enrolls adults aged 18–70 whose condition has lasted more than 28 days but less than one year and who are diagnosed as vegetative state (VS) or minimally conscious state (MCS) by the Coma Recovery Scale–Revised (CRS-R). Key exclusions include recent seizures, pacemakers or cranial metal implants, concurrent neuromodulation trials, and medications that interfere with cerebral stimulation; skin at the auricular site must be intact. Participants receive taVNS while clinicians monitor behavioral responses with CRS-R and record brain activity with EEG at the single center in Guangzhou.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18-70 years, with a disease duration exceeding 28 days but not longer than 1 year.
* Patients diagnosed with disorders of consciousness (DoC), specifically classified as either vegetative state (VS) or minimally conscious state (MCS) according to the Coma Recovery Scale-Revised (CRS-R) based on international guidelines.
* No prior history of neuropsychiatric disorders.
* Absence of contraindications to transcutaneous auricular vagus nerve stimulation (taVNS) or electroencephalography (EEG), and no concurrent use of sedatives or medications that may interfere with cerebral stimulation-including Na⁺ or Ca²⁺ channel blockers or NMDA receptor antagonists.
* Intact skin at the auricular site.

Exclusion Criteria:

* Participation in other trials involving non-invasive or invasive neuromodulation.
* Uncontrolled epilepsy, defined as seizures occurring within 4 weeks prior to enrollment.
* Presence of cranial metal implants, pacemakers, craniotomy at the stimulation site, implanted brain devices, or similar conditions.
* Cardiac arrhythmia or other significant cardiovascular abnormalities;
* History of respiratory disorders, including dyspnea, asthma, or hyperventilation.
* History of vasovagal syncope.

Where it's running

• Zhujiang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: xiaoya Xiong
• Email: xiongxiaoya0224@163.com
• Phone: 13392929402

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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.