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
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
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- 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.
- 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