Headache Clinical Trials

Find Headache Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Capital Medical University Affiliated Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Qingyuan Liu, M.D.
13260457220@163.com
+86-13260457220
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2027-07
Participants
Target number of participants: 440
Treatments
Experimental: Experimental Group
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_comparator: Control Group
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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov