Study of Transcutaneous Auricular Vagus Nerve Stimulation to Reduce Headaches After Stent Treatment for Unruptured Brain Aneurysms

What this Trial Is About

Researchers are evaluating transcutaneous auricular vagus nerve stimulation taVNS to see if it can reduce postoperative headaches in adults aged 18 to 80 years undergoing stent-assisted coiling or flow diverter embolization for unruptured intracranial aneurysms UIAs. The study aims to determine if taVNS decreases the occurrence of headaches within 90 days after treatment and assesses its safety and tolerability in this group. Participants will be randomly assigned to receive either active taVNS or sham stimulation. The active group will use a taVNS device applied to the left cymba conchae starting 24 hours before surgery until 5 days after, with 30-minute stimulation sessions twice daily. The sham group will have the device placed on the left earlobe without electrical current but with the same schedule and parameters. Stimulation parameters include a pulse width of 200-300 microseconds at 25 Hz, alternating 30 seconds on and 30 seconds off. During the study, participants will be monitored for headache incidence, pain levels using a visual analog scale, analgesic use, and any side effects through 90 days after the procedure. Researchers will also measure blood inflammatory cytokines on postoperative days 5 and 90. Safety assessments will focus on adverse events related to taVNS from 24 hours before surgery to 5 days after. Follow-up visits and evaluations will track both efficacy and safety outcomes throughout the study period.

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