Transcutaneous auricular vagus nerve stimulation for people with disorders of consciousness

Effects of Pairing Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness: An Exploratory Single-Center Randomized Controlled Trial

This test tries transcutaneous auricular vagus nerve stimulation (taVNS) to see if it helps adults who are in a vegetative state or a minimally conscious state.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07284732 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–70 years old with a diagnosis of VS or MCS by CRS-R, between 28 days and one year after severe brain injury, medically stable, and without implants or medications that would interfere with stimulation.

Not a fit: Patients with uncontrolled epilepsy, seizures in the past four weeks, cranial metal implants or pacemakers, recent craniotomy at the stimulation site, or on interfering medications are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, taVNS could improve levels of consciousness and functional recovery for some patients with disorders of consciousness.

How similar studies have performed: Small case reports and early small trials of invasive and noninvasive vagus nerve stimulation in disorders of consciousness have reported mixed but sometimes promising signals, though larger controlled trials remain limited.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: xiaoya Xiong

Conditions Disorders of Consciousness