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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcutaneous Auricular Vagus Nerve Stimulation: 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 stimulation: 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 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

Eligibility

Primary outcome measure(s)

• Primary efficacy outcome: Incidence of headache within postoperative day 5 to day 90 — 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 — 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 — Postoperative day 5-90
  Number of days with moderate to severe headache (VAS ≥ 4) between postoperative day 5-90

Trial sites (1)

More Beijing Tiantan Hospital trials in China

Other trials for the same condition