🏛️ Verified NIH Record • Updated 2026-05-29
nVNS, CBD, and SoC for Persistent Post-Traumatic Headache (NCT07624279)
🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: American Society of Pain and Neuroscience, Inc.
🩺 Plain-English Summary (8th-Grade Level)
Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (19 items).
Location: Mayo Clinic — Scottsdale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- EXCLUSION CRITERIA
- Body weight at screening of less than 40 kg
- Other severe pain condition (e.g., cancer pain or trigeminal neuralgia) that, in the discretion of the investigator, may confound the study assessments
- Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure), neurologic disease (history of intracranial aneurysm, intracranial hemorrhage, or brain tumor), moderate to severe hepatic impairment, history of cervical surgery (e.g. cervical vagotomy) that in the judgment of the investigator would interfere with the study, or other major medical problems at the discretion of the investigator
- Psychiatric, substance abuse, or cognitive disorder and/or behavioral problems that, in the opinion of the investigator, may interfere with the study.
- Belongs to a vulnerable population (e.g., developmentally disabled, prisoner) or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised at the discretion of the investigator
- Currently takes prescription opioids more than 4 days per month for any indication
- Patients receiving PREEMPT protocol onabotulinumtoxin injections, nerve blocks (occipital or other), steroid injections, radiofrequency ablations, and/or trigger point injections in the head or neck injections within the prior 12 weeks must continue receiving this procedure on a regular schedule at the discretion of the investigator during the course of the study. Patients who experience "wear-off" effects or increases in headache days during the last two weeks of their procedural cycles will be excluded from the study
- Currently implanted with a cardiac defibrillator
- Allergy to CBD or other components of Cannabis sativa L. (including hemp or cannabis)
- Previously used gammaCore or high-dose CBD (\>100mg/day) for PPTH
- Used medical marijuana, cannabis, hemp or CBD-based product within 30 days prior to the study
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Mayo Clinic — Scottsdale, Arizona
- Kerlan-Jobe Orthopaedic Institute — Los Angeles, California
- International Spine, Pain & Performance Center — Washington D.C., District of Columbia
- Florida Spine & Pain Specialists — Tampa, Florida
- University of Kansas Medical Center — Kansas City, Kansas
- Premier Pain Center — Shrewsbury, New Jersey
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Allegheny General Hospital — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.