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New treatment option for Intracerebral Hemorrhage
Official title TaVNS for Acute Intracerebral Hemorrhage
ClinicalTrials.gov ID: NCT06918964
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with acute intracerebral hemorrhage (ICH). The taVNS intervention will be delivered using the BS-TVNS800-1 transcutaneous electrical stimulation therapy device (KERFUN, Shanxi, China).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with spontaneous supratentorial intracerebral hemorrhage.
- Age between 18 and 80 years.
- Onset within 72 hours.
- Hematoma volume between 5 and 40 mL.
- Glasgow Coma Scale (GCS) score greater than 8.
You likely can't join if
- Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
- Primary intraventricular hemorrhage.
- Parenchymal hemorrhage that ruptures into the ventricles, with blood completely filling one lateral ventricle, the third ventricle, the fourth...
- Progressive neurological or other severe diseases.
- Planned surgical treatment within 24 hours.
- Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
See the full eligibility criteria
- Patients with spontaneous supratentorial intracerebral hemorrhage.
- Age between 18 and 80 years.
- Onset within 72 hours.
- Hematoma volume between 5 and 40 mL.
- Glasgow Coma Scale (GCS) score greater than 8.
- Written informed consent obtained from the patient or their legal representative.
- Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
- Primary intraventricular hemorrhage.
- Parenchymal hemorrhage that ruptures into the ventricles, with blood completely filling one lateral ventricle, the third ventricle, the fourth ventricle or more than half of both lateral ventricles.
- Progressive neurological or other severe diseases.
- Planned surgical treatment within 24 hours.
- Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
- Patients with severe cardiomyopathy, heart failure, pacemaker implantation, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or other severe arrhythmias.
- Severe pulmonary disease, liver disease, renal insufficiency (glomerular filtration rate \< 30 mL/min), active gastrointestinal bleeding, or malignant tumors with an expected survival of less than 3 months.
- Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
- Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) within 7 days before screening.
- Patients who cannot tolerate taVNS.
- Congenital or acquired ear abnormalities preventing taVNS treatment.
- Inability to comply with 10 days of treatment.
- Pregnancy or within 30 days of delivery.
- Participation in another treatment clinical trial.
- Inability to obtain written informed consent from the participant or their legal representative.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.