Actively Recruiting
Effects of Pairing Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness: An Exploratory Single-Center Randomized Controlled Trial
Led by Zhujiang Hospital · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Disorders of consciousness (DoC) include serious conditions like Unresponsive Wakefulness Syndrome and Minimally Conscious State, which follow severe brain injuries and affect awareness and cognition. These conditions are challenging to diagnose and treat, with many new cases each year in China. Researchers are studying the effects of a non-invasive brain stimulation method called transcutaneous auricular vagus nerve stimulation (taVNS), which has shown potential in treating various neurological conditions and may help improve awareness in patients with DoC. In this single-arm trial, 20 patients with DoC will receive taVNS treatments twice daily for 10 consecutive days, totaling 20 sessions. The stimulation is applied to the left cymba conchae of the ear using a silicone electrode, delivering pulse trains at 100 Hz with 400 paired pulses per session. This study aims to explore the therapeutic role of taVNS by comparing patients' conditions before and after the treatment period. Participants will be assessed using the Coma Recovery Scale-Revised (CRS-R) to measure changes in behavioral responses immediately after the 10-day treatment. Researchers will also record resting-state high-density EEG and combined transcranial magnetic stimulation with EEG (TMS-EEG) to study brain activity changes. The study will provide important information to guide treatment choices for patients with disorders of consciousness, with all evaluations conducted during the treatment period and immediately after.
CONDITIONS
Brief Title
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years, with a disease duration exceeding 28 days but not longer than 1 year
- Diagnosed with disorders of consciousness (vegetative state or minimally conscious state) based on the Coma Recovery Scale-Revised
- No prior history of neuropsychiatric disorders
- No contraindications to transcutaneous auricular vagus nerve stimulation or EEG
- Not currently using sedatives or medications that interfere with brain stimulation, including Na+ or Ca2+ channel blockers or NMDA receptor antagonists
- Intact skin at the auricular stimulation site
You will not qualify if you...
- Participation in other trials involving non-invasive or invasive neuromodulation
- Uncontrolled epilepsy with seizures within 4 weeks before enrollment
- Presence of cranial metal implants, pacemakers, craniotomy at the stimulation site, or implanted brain devices
- Cardiac arrhythmia or other significant cardiovascular abnormalities
- History of respiratory disorders such as dyspnea, asthma, or hyperventilation
- History of vasovagal syncope
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 days
Participants receive transcutaneous auricular vagus nerve stimulation twice daily for 10 consecutive days.
20 stimulation sessions (twice daily)
Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
Research Team
X
xiaoya Xiong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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