Can a gentle ear zap wake the brain after a bleed?
NCT ID NCT07761507
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether a gentle electrical stimulation applied to the ear—called transcutaneous auricular vagus nerve stimulation—can help people recover consciousness after surgery for a spontaneous brain hemorrhage. The study will include 160 adults aged 18 to 75 who remain in a disorder of consciousness five days after surgery. Half will receive the active stimulation and half a sham (inactive) device, worn for 8 hours daily over 6 weeks, with the goal of seeing if more people regain awareness by day 90.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagus nerve stimulation (taVNS), a noninvasive device that delivers mild electrical pulses to the ear
- What this could lead to
- If effective, this could offer a safe, noninvasive way to help people recover consciousness after severe brain hemorrhage surgery, potentially reducing long-term disability.
- What could go wrong
- This is a relatively small, early-stage trial, and the treatment may not improve outcomes. The stimulation is generally well-tolerated but could cause discomfort or skin irritation at the ear site.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Capital Medical University Affliated Beijing Tiantan Hospital, Beijing, Beijing
RECRUITINGBeijing, China
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Other studies related to the condition(s) this trial covers.
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