Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Headache Following Stent-Assisted Coiling of Unruptured Intracranial Aneurysms

NCT07479082 | Recruiting

• 1 other identifier: KY2025-284
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Unruptured Intracranial Aneurysm; Headache; Vagus Nerve Stimulations

Keywords

Unruptured Intracranial Aneurysm; Postoperative Headache; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (3)

• 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).

  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)

  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

  Postoperative day 5-90

Secondary Outcomes (5)

• Headache incidence within postoperative day 5-30

  Postoperative day 5 to day 30

• VAS (Visual Analog Scale) scores on postoperative day 30 and 90

  Postoperative day 30 and 90

• Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-30

  Postoperative day 5-30

• Postoperative day 5 levels of blood inflammatory cytokines

  Postoperative day 5

• Postoperative day 90 levels of blood inflammatory cytokines

  Postoperative day 90

Study Arms (2)

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.

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.

Device: Sham transcutaneous auricular vagus nerve stimulation

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

Experimental Group

Sham transcutaneous auricular vagus nerve stimulation DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to follow up due to severe psychiatric disorder or refusal
• Skin lesions at taVNS placement site
• Pregnant or lactating
• Participation in other trials

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qingyuan Liu, M.D.

CONTACT

+86-13260457220; 13260457220@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 18, 2026
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2025-08

Locations

CN (1)