Intracerebral HemorrhageTAVANS-ICHNCT06918964
TaVNS for Acute Intracerebral Hemorrhage
A study testing transcutaneous auricular vagus nerve stimulation device in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- transcutaneous auricular vagus nerve stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 interventional clinical trial.
- Inability to obtain written informed consent from the participant or their legal representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Kaijiang Kang, MD, +8618210554710, kangkaijiang678@126.com
Chuanying Wang, MD, +8618515356680, chuanying616@163.com
About this study
Official title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Acute Intracerebral Hemorrhage
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 total of 186 patients will be randomly assigned in a 1:1 ratio to either the taVNS group or the sham-taVNS group. The primary outcome is the relative volume of perihematoma edema assessed on day 10-14 after randomization. Adverse events associated with taVNS therapy will be systematically evaluated to assess its safety profile.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- transcutaneous auricular vagus nerve stimulation device, Sham device
- Keywords
- Intracerebral Hemorrhage, taVNS, perihemtomal edema, neuroinflammation, secondary brain injury
- Medical subject headings
- Cerebral Hemorrhage, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulation deviceDevice
Place the stimulation device on the left auricle and set the stimulation parameters according to the following conditions: a. Waveform: biphase, square wave; b. Wave width: 200 μs; c. Frequency: Alternating between low frequency (4 Hz for 4 s), high frequency (40 Hz for 8 s), and a 4 s pause; d. Intensity: The maximum intensity that induces the strongest sensation the individual can tolerate without causing pain, usually 1.5-3.5 mA; e. Treatment duration: Each treatment lasted 30 minutes, twice daily (8:00, 16:00) for 10 days.
Sham deviceDevice
The sham taVNS group received the same parameters with a current intensity of 0.06 mA.
| Study group | Role | What they receive |
|---|---|---|
| taVNS intervention | Active comparator | Patients will receive taVNS therapy twice daily for 10 consecutive days, in addition to receiving guideline-adherent conventional treatment during hospitalization. Receives: Device: transcutaneous auricular vagus nerve stimulation device |
| Sham taVNS intervention | Sham comparator | Patients will receive sham taVNS twice daily for 10 consecutive days, in addition to receiving guideline-adherent conventional treatment during their hospital stay. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of perihematoma edema assessed by CT
Relative edema volume.
Measured: Day 10-14 after randomization
Secondary outcomes (14)
Autonomic activity assessed by heart rate variability
Heart rate variability (HRV) will be assessed using a 10-minute electrocardiogram (ECG) recorded with a 12-lead ECG Holter (TeleECG BI 12E, Biomedical Instruments Co., Ltd., Shenzhen). HRV indices will be analyzed in both the time domain (e.g., SDNN, RMSSD) and the frequency domain (e.g., LF, HF, LF/HF).
Measured: Day 10-14 after randomization
Autonomic activity assessed by baroreflex sensitivity
Baroreflex sensitivity (BRS) will be evaluated by noninvasively measuring beat-to-beat signals for 10 min using a servo-controlled plethysmograph (FMS-8A, Delica Medical Equipment Co., Ltd., Shenzhen) placed on the middle finger.
Measured: Day 10-14 after randomization
National Institutes of Health stroke scale (NIHSS)
NIHSS is used to assess the severity of functional impairment caused by stroke. It consists of 11 test items, with a total score ranging from 0 to 42. A higher score indicates a more severe stroke.
Measured: Day 10-14 after randomization
GCS (Glasgow Coma Scale)
The GCS is used to assess the level of consciousness in patients, with the total score ranging from 3 to 15. Lower scores indicate more severe impairment.
Measured: Day 10-14 after randomization
MMSE (Mini-Mental State Examination)
The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool designed to assess global cognitive function, including orientation, memory, attention, language, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Day 10-14 after randomization
MoCA (Montreal Cognitive Assessment)
The Montreal Cognitive Assessment (MoCA) is another cognitive screening instrument optimized for detecting mild cognitive impairment (MCI) and early dementia. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Day 10-14 after randomization
PHQ-9 (Patient Health Questionnaire-9)
The Patient Health Questionnaire-9 (PHQ-9) is a brief, self-report tool validated for screening and monitoring depression severity. Scores range from 0 to 27, with higher scores reflecting greater symptom severity.
Measured: Day 10-14 after randomization
90-day National Institutes of Health stroke scale (NIHSS)
NIHSS is used to assess the severity of functional impairment caused by stroke. It consists of 11 test items, with a total score ranging from 0 to 42. A higher score indicates a more severe stroke.
Measured: 90 ± 7 days after randomization
90-day modified Rankin Scale (mRS)
The mRS is used to measure the degree of disability or dependence after a stroke. The scale ranges from 0 to 6 and higher scores indicate greater functional impairment.
Measured: 90 ± 7 days after randomization
90-day EQ-5D (EuroQol 5-Dimension Questionnaire) score
The EQ-5D is a standardized instrument used to assess health-related quality of life.
Measured: 90 ± 7 days after randomization
90-day GCS (Glasgow Coma Scale)
The GCS is used to assess the level of consciousness in patients, with the total score ranging from 3 to 15. Lower scores indicate more severe impairment.
Measured: 90 ± 7 days after randomization
90-day MMSE (Mini-Mental State Examination)
The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool designed to assess global cognitive function, including orientation, memory, attention, language, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: 90 ± 7 days after randomization
90-day MoCA (Montreal Cognitive Assessment)
The Montreal Cognitive Assessment (MoCA) is another cognitive screening instrument optimized for detecting mild cognitive impairment (MCI) and early dementia. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: 90 ± 7 days after randomization
90-day PHQ-9 (Patient Health Questionnaire-9)
The Patient Health Questionnaire-9 (PHQ-9) is a brief, self-report tool validated for screening and monitoring depression severity. Scores range from 0 to 27, with higher scores reflecting greater symptom severity.
Measured: 90 ± 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaijiang Kang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918964
- Sponsor's protocol ID
- KangKJ
- Acronym
- TAVANS-ICH
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Acute Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06918964
- Acronym / sponsor ID
- TAVANS-ICH / KangKJ
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, taVNS, perihemtomal edema, neuroinflammation, secondary brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 total of 186 patients will be randomly assigned in a 1:1 ratio to either the taVNS group or the sham-taVNS group. The primary outcome is the relative volume of perihematoma edema assessed on day 10-14 after randomization. Adverse events associated with taVNS therapy will be systematically evaluated to assess its safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS intervention | Active comparator | Device: transcutaneous auricular vagus nerve stimulation devicePatients will receive taVNS therapy twice daily for 10 consecutive days, in addition to receiving guideline-adherent conventional treatment during hospitalization. |
| Sham taVNS intervention | Sham comparator | Device: Sham devicePatients will receive sham taVNS twice daily for 10 consecutive days, in addition to receiving guideline-adherent conventional treatment during their hospital stay. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation devicePlace the stimulation device on the left auricle and set the stimulation parameters according to the following conditions: a. Waveform: biphase, square wave; b. Wave width: 200 μs; c. Frequency: Alternating between low frequency (4 Hz for 4 s), high frequency (40 Hz for 8 s), and a 4 s pause; d. Intensity: The maximum intensity that induces the strongest sensation the individual can tolerate without causing pain, usually 1.5-3.5 mA; e. Treatment duration: Each treatment lasted 30 minutes, twice daily (8:00, 16:00) for 10 days. | Device | taVNS intervention |
| Sham deviceThe sham taVNS group received the same parameters with a current intensity of 0.06 mA. | Device | Sham taVNS intervention |
Primary outcome
Volume of perihematoma edema assessed by CT
Time frame: Day 10-14 after randomization
Relative edema volume.
14 secondary outcomes
Autonomic activity assessed by heart rate variability
Time frame: Day 10-14 after randomization
Autonomic activity assessed by baroreflex sensitivity
Time frame: Day 10-14 after randomization
National Institutes of Health stroke scale (NIHSS)
Time frame: Day 10-14 after randomization
GCS (Glasgow Coma Scale)
Time frame: Day 10-14 after randomization
MMSE (Mini-Mental State Examination)
Time frame: Day 10-14 after randomization
MoCA (Montreal Cognitive Assessment)
Time frame: Day 10-14 after randomization
PHQ-9 (Patient Health Questionnaire-9)
Time frame: Day 10-14 after randomization
90-day National Institutes of Health stroke scale (NIHSS)
Time frame: 90 ± 7 days after randomization
90-day modified Rankin Scale (mRS)
Time frame: 90 ± 7 days after randomization
90-day EQ-5D (EuroQol 5-Dimension Questionnaire) score
Time frame: 90 ± 7 days after randomization
90-day GCS (Glasgow Coma Scale)
Time frame: 90 ± 7 days after randomization
90-day MMSE (Mini-Mental State Examination)
Time frame: 90 ± 7 days after randomization
90-day MoCA (Montreal Cognitive Assessment)
Time frame: 90 ± 7 days after randomization
90-day PHQ-9 (Patient Health Questionnaire-9)
Time frame: 90 ± 7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation device in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of perihematoma edema assessed by CT (time frame: Day 10-14 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.