A Phase 2 Randomized, Multicenter Study of Non-Invasive Vagus Nerve Stimulation (nVNS), Cannabidiol, and Standard of Care for the Treatment of Persistent Post-Traumatic Headache in Elite Athletes
American Society of Pain and Neuroscience, Inc.
Summary
Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?
Description
In this randomized, open-label clinical trial, athletes with persistent post-traumatic headache will be treated with either non-invasive vagal nerve stimulation, cannabidiol, or standard of care oral pharmacotherapy for 12 weeks.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA 1. Between the ages of 18 and 75 years inclusive 2. Participated in competitive sports at high school level or beyond or, in the case of sports without interscholastic competition, as per investigator 3. Persistent headache attributed to traumatic injury to the head in accordance with the ICHD-3 criteria (including "Headache persists for \>3 months after its onset") 4. Experiences 4-25 (inclusive) headaches days per month (during the 28-day baseline period), with at least 4 of them being moderate or severe in intensity 5. Completed at least 80% (23 of 28 days) on 28-day bas…