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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulation
  • Sham transcutaneous auricular vagus nerve stimulation

Treatment groups

440 Participants
are divided into 2 treatment groups

Locations

1
Capital Medical University Affiliated Beijing Tiantan Hospital BeijingBeijing Municipality, China

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor