Unruptured Intracranial AneurysmIMPACT-HTNCT07479082
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Unruptured Intracranial Aneurysm and Headache, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing postoperative headache among adults undergoing stent-assisted coiling for unruptured intracranial aneurysms (UIAs). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Headache, Vagus Nerve Stimulations
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to Jul 2027
- 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
- Age 18-80 years
- Diagnosed with unruptured intracranial aneurysm confirmed by imaging
- Planned to undergo stent-assisted coiling or flow diverter embolization
- Signed informed consent
Who cannot join
- History of SAH, ICH, brain tumor, major trauma, substance abuse, syncope, or seizures
- Recurrent/traumatic/infectious/myxomatous aneurysms
- Primary headache disorders (e.g., migraine, cluster headache, trigeminal neuralgia) not attributed to UIA
- Previous vagotomy, migraine surgery, or implanted neurostimulators
- Other concurrent electronic/implantable devices (e.g., pacemakers, neurostimulators)
- Clinically significant hypotension, congenital heart disease, severe arrhythmia, unstable angina, or recent MI
Show all 10Show fewer
- Inability to follow up due to severe psychiatric disorder or refusal
- Skin lesions at taVNS placement site
- Pregnant or lactating
- Participation in other trials
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
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
Qingyuan Liu, M.D., +86-13260457220, 13260457220@163.com
Shuo Wang, M.D.
About this study
The goal of this clinical trial is to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing postoperative headache among adults undergoing stent-assisted coiling for unruptured intracranial aneurysms (UIAs). The study will include male and female participants aged 18 to 80 years who are scheduled for endovascular treatment of UIAs with stent-assisted coiling or flow diverter devices.
The main questions it aims to answer are:
Read more
- Can taVNS reduce the incidence of headache within 90 days after stent-assisted embolization of UIAs?
- Is taVNS safe and well-tolerated in this patient population? Researchers will compare patients receiving active taVNS to those receiving sham stimulation to determine if taVNS leads to fewer postoperative headaches and reduced need for analgesic medications.
Participants will:
- Wear a taVNS device on the left earlobe (active group) or cymba conchae (sham group) starting 1 day before the procedure
- Receive 30-minute stimulation sessions, twice daily, until postoperative day 5
- Undergo follow-up assessments of headache occurrence, pain intensity, analgesic use, and any adverse events through day 90 after the procedure
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Sham transcutaneous auricular vagus nerve stimulation
- Keywords
- Unruptured Intracranial Aneurysm, Postoperative Headache, Vagus Nerve Stimulation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Participants will receive transcutaneous auricular vagus nerve stimulation via a taVNS device applied to the left cymba conchae starting 24 hours before surgery to 5 days after surgery. Stimulation will be administered twice daily, with a 12-hour interval between sessions. Parameters: pulse width of 200-300 µs at 25 Hz and a biphasic pulse interval of 30 s ON and 30 s OFF. The stimulus intensity of the tVNS varied between individuals and is set to the average level, which is defined by the level above the detection threshold but below the pain perception threshold.
Sham transcutaneous auricular vagus nerve stimulationDevice
Participants will receive transcutaneous auricular vagus nerve stimulation but without electrical current via a taVNS device applied to the left earlobe starting 24 hours before surgery twice daily until postoperative day 5. Stimulation parameters, frequency and duration are identical to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive transcutaneous auricular vagus nerve stimulation via a taVNS device applied to the left cymba conchae starting 24 hours before surgery to 5 days after surgery. Stimulation will be administered twice daily, with a 12-hour interval between sessions.
Parameters: pulse width of 200-300 µs at 25 Hz and a biphasic pulse interval of 30 s ON and 30 s OFF. The stimulus intensity of the tVNS varied between individuals and is set to the average level, which is defined by the level above the detection threshold but below the pain perception threshold. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Control Group | Sham comparator | Sham stimulation with the device placed at the left cymba conchae without electrical current. Stimulation parameters, frequency and duration are identical to the experimental group. Receives: Device: Sham transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90
Incidence of headache within postoperative day 5 to day 90, defined as headache lasting ≥4 hours or requiring acute analgesic treatment, excluding secondary causes (e.g., hemorrhage, trauma).
Measured: Postoperative day 5 to day 90
Primary safety outcome: Incidence of taVNS-related adverse events
Incidence of taVNS-related adverse events:
- Bradycardia (HR < 50 bpm for ≥5 minutes)
- Hypotension (MAP drop > 20 mmHg or >30% from baseline)
- ECG abnormalities (ST changes or arrhythmias confirmed by cardiologist)
- Symptomatic cerebral infarction (NIHSS score increase ≥2 with imaging evidence within 24h)
- Local skin complications (redness, pain, injury ≥24h)
Measured: From 24 hr before surgery to 5 days after surgery
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90
Measured: Postoperative day 5-90
Secondary outcomes (5)
Headache incidence within postoperative day 5-30
Incidence of headache within postoperative day 5 to day 30, defined as headache lasting ≥4 hours or requiring acute analgesic treatment, excluding secondary causes (e.g., hemorrhage, trauma).
Measured: Postoperative day 5 to day 30
VAS (Visual Analog Scale) scores on postoperative day 30 and 90
VAS (Visual Analog Scale) scores on postoperative day 30 and 90. Visual Analog Scale (range: 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain outcomes.
Measured: Postoperative day 30 and 90
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30
Measured: Postoperative day 5-30
Postoperative day 5 levels of blood inflammatory cytokines
Postoperative day 5 levels of blood inflammatory cytokines
Measured: Postoperative day 5
Postoperative day 90 levels of blood inflammatory cytokines
Postoperative day 90 levels of blood inflammatory cytokines
Measured: Postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start30 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Intracranial AneurysmStudies 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479082
- Sponsor's protocol ID
- KY2025-284
- Acronym
- IMPACT-HT
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 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 Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT07479082
- Acronym / sponsor ID
- IMPACT-HT / KY2025-284
- Keywords
- Unruptured Intracranial Aneurysm, Postoperative Headache, Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Mar 2026 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing postoperative headache among adults undergoing stent-assisted coiling for unruptured intracranial aneurysms (UIAs). The study will include male and female participants aged 18 to 80 years who are scheduled for endovascular treatment of UIAs with stent-assisted coiling or flow diverter devices.
The main questions it aims to answer are:
- Can taVNS reduce the incidence of headache within 90 days after stent-assisted embolization of UIAs?
- Is taVNS safe and well-tolerated in this patient population? Researchers will compare patients receiving active taVNS to those receiving sham stimulation to determine if taVNS leads to fewer postoperative headaches and reduced need for analgesic medications.
Participants will:
- Wear a taVNS device on the left earlobe (active group) or cymba conchae (sham group) starting 1 day before the procedure
- Receive 30-minute stimulation sessions, twice daily, until postoperative day 5
- Undergo follow-up assessments of headache occurrence, pain intensity, analgesic use, and any adverse events through day 90 after the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationParticipants will receive transcutaneous auricular vagus nerve stimulation via a taVNS device applied to the left cymba conchae starting 24 hours before surgery to 5 days after surgery. Stimulation will be administered twice daily, with a 12-hour interval between sessions. Parameters: pulse width of 200-300 µs at 25 Hz and a biphasic pulse interval of 30 s ON and 30 s OFF. The stimulus intensity of the tVNS varied between individuals and is set to the average level, which is defined by the level above the detection threshold but below the pain perception threshold. |
| Control Group | Sham comparator | Device: Sham transcutaneous auricular vagus nerve stimulationSham stimulation with the device placed at the left cymba conchae without electrical current. Stimulation parameters, frequency and duration are identical to the experimental group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Diagnosed with unruptured intracranial aneurysm confirmed by imaging
- Planned to undergo stent-assisted coiling or flow diverter embolization
- Signed informed consent
Key exclusion criteria (10 listed)
- History of SAH, ICH, brain tumor, major trauma, substance abuse, syncope, or seizures
- Recurrent/traumatic/infectious/myxomatous aneurysms
- Primary headache disorders (e.g., migraine, cluster headache, trigeminal neuralgia) not attributed to UIA
- Previous vagotomy, migraine surgery, or implanted neurostimulators
- Other concurrent electronic/implantable devices (e.g., pacemakers, neurostimulators)
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 StimulationParticipants will receive transcutaneous auricular vagus nerve stimulation via a taVNS device applied to the left cymba conchae starting 24 hours before surgery to 5 days after surgery. Stimulation will be administered twice daily, with a 12-hour interval between sessions. Parameters: pulse width of 200-300 µs at 25 Hz and a biphasic pulse interval of 30 s ON and 30 s OFF. The stimulus intensity of the tVNS varied between individuals and is set to the average level, which is defined by the level above the detection threshold but below the pain perception threshold. | Device | Experimental Group |
| Sham transcutaneous auricular vagus nerve stimulationParticipants will receive transcutaneous auricular vagus nerve stimulation but without electrical current via a taVNS device applied to the left earlobe starting 24 hours before surgery twice daily until postoperative day 5. Stimulation parameters, frequency and duration are identical to the experimental group. | Device | Control Group |
Primary outcome
Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90
Time frame: Postoperative day 5 to day 90
Incidence of headache within postoperative day 5 to day 90, defined as headache lasting ≥4 hours or requiring acute analgesic treatment, excluding secondary causes (e.g., hemorrhage, trauma).
Primary safety outcome: Incidence of taVNS-related adverse events
Time frame: From 24 hr before surgery to 5 days after surgery
Incidence of taVNS-related adverse events: * Bradycardia (HR < 50 bpm for ≥5 minutes) * Hypotension (MAP drop > 20 mmHg or >30% from baseline) * ECG abnormalities (ST changes or arrhythmias confirmed by cardiologist) * Symptomatic cerebral infarction (NIHSS score increase ≥2 with imaging evidence within 24h) * Local skin complications (redness, pain, injury ≥24h)
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90
Time frame: Postoperative day 5-90
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90
5 secondary outcomes
Headache incidence within postoperative day 5-30
Time frame: Postoperative day 5 to day 30
VAS (Visual Analog Scale) scores on postoperative day 30 and 90
Time frame: Postoperative day 30 and 90
Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30
Time frame: Postoperative day 5-30
Postoperative day 5 levels of blood inflammatory cytokines
Time frame: Postoperative day 5
Postoperative day 90 levels of blood inflammatory cytokines
Time frame: Postoperative day 90
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 18 Mar 2026.
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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.
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 in people with Unruptured Intracranial Aneurysm and Headache, 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 4 inclusion and 10 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 18 Mar 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?
Contact Qingyuan Liu, M.D. (+86-13260457220, 13260457220@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90 (time frame: Postoperative day 5 to day 90). The study lists 3 primary outcomes in all. 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 18 Mar 2026.