Introduction
Primary headaches are a major issue for children and teenagers, showing the need for effective treatments that do not rely on medications. One promising method is called transcutaneous auricular vagus nerve stimulation (taVNS), which is a non-invasive treatment that has worked well for adults with headaches and has been deemed safe for adolescents with mental health issues. However, we still need to explore how well it works for kids and teens experiencing headaches.
Study Goals
This study aims to:
- Test how well taVNS reduces headache pain during acute episodes.
- See if taVNS can help prevent headaches over a four-week period.
- Investigate possible biological markers related to headaches.
- Understand how taVNS works through specific tests.
Study Design
We will conduct a double-blind, randomized clinical trial with 288 children and adolescents who have primary headaches. The study has two parts:
- Acute Period Study: Participants will receive either taVNS or a placebo treatment, and we will measure pain reduction two hours after treatment.
- Preventive Period Study: We will track the number of headache days over four weeks.
Ethics and Approval
The study follows ethical guidelines and has been approved by the Medical Ethics Committee of Nanfang Hospital. Informed consent will be obtained from participants or their guardians.
Measurable Outcomes
Clear goals will be set to measure the effectiveness of taVNS in treating and preventing headaches. This will help clinics and patients understand the benefits of this treatment.
AI Tools for Clinical Needs
We will explore AI solutions that fit the specific needs of this clinical trial, enhancing our understanding and management of headache treatments.
Implementation Steps
We will start with a pilot project to track results using AI tools, ensuring we can see the real-world impact of taVNS on headache management.
Contact Us
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