Transcutaneous auricular vagus nerve stimulation to help regain consciousness after surgery for brain hemorrhage

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 multicenter, randomized trial compares active transcutaneous auricular vagus nerve stimulation (taVNS) to sham stimulation in adults 18–75 who recently had hematoma evacuation for spontaneous intracerebral hemorrhage and are still unconscious on postoperative day 5. Participants receive 8 hours of taVNS daily for 6 weeks, with outcomes assessed up to 90 days using standardized measures of consciousness. The trial also includes mechanistic substudies to explore changes in brain networks, blood flow, metabolism, inflammation, neural injury, and autonomic regulation to understand how taVNS might aid recovery. Primary outcome is the proportion of patients who remain in a disorder of consciousness at the end of the observation period. Safety and standard postoperative care are aligned with local clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Spontaneous intracerebral hemorrhage.
* Age 18 to 75 years.
* Surgical intervention performed within 48 hours after symptom onset.
* Glasgow Coma Scale score of 5 to 9 on postoperative day 5 while the participant is not sedated; for intubated participants, the verbal component is scored as 1T.
* Surgical hematoma evacuation by craniotomy, endoscopic evacuation, or minimally invasive aspiration/fragmentation.
* Written informed consent provided by the participant's legally authorized representative.

Exclusion Criteria:

* • Intracranial hemorrhage caused by a confirmed intracranial aneurysm, cerebral vascular malformation, intracranial tumor, arterial thrombosis, or venous thrombosis.

  * Injury to critical brain structures affecting consciousness, including brainstem hemorrhage or thalamic hemorrhage greater than 20 mL.
  * Isolated intraventricular hemorrhage.
  * Severe cardiomyopathy, heart failure, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or another severe cardiac arrhythmia.
  * Unstable postoperative vital signs, defined as systolic blood pressure below 90 mm Hg or heart rate below 50 beats per minute.
  * New cerebral infarction or recurrent intracranial hemorrhage between surgery and randomization.
  * Acute myocardial ischemia or myocardial infarction between surgery and randomization.
  * Previous vagus nerve electrical stimulation, previous cervical vagotomy, concurrent use of another stimulation device, or presence of an implanted electronic medical device, including a muscle stimulator, cardiac pacemaker, hearing aid, or any other implanted electronic device.
  * Skin breakdown, infection, erythema, or another condition at the electrode-placement site that makes taVNS unsuitable.
  * Pregnant, peripartum, or postpartum women.
  * Current participation in another clinical trial.

Where it's running

• Capital Medical University Affliated Beijing Tiantan Hospital, Beijing, Beijing
  Beijing, China Recruiting

Study contacts

• Study coordinator: Qingyuan Liu, M.D.
• Email: 13260457220@163.com
• Phone: +86-13260457220

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• Transcutaneous auricular vagus nerve stimulation for people with disorders of consciousness

  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.

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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.