nVNS, CBD, and SoC for Persistent Post-Traumatic Headache
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- American Society of Pain and Neuroscience, Inc.
- Study ID
- NCT07624279
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Persistent Post Traumatic Headache
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Non-Invasive Vagus Nerve Stimulation — DEVICETwo treatments to the cervical vagus nerve twice daily
- Cannabidiol — DRUGDosage titrated as per schedule
- Standard of Care — DRUGOral pharmacotherapy as selected by site investigator and participant
Study Details
Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- May 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 1, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Non-Invasive Vagus Nerve Stimulation
- Experimental: Cannabidiol
- Experimental: Standard of Care
Primary Outcome Measure
Moderate-severe headache days [ Time Frame: Weeks 9-12 ]
Central Contacts
- Nathaniel M Schuster, MD(858) 249-3800
- Erika A Petersen501-686-5270
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85054 | Natalie Strand, MD Natalie Strand, MD (PRINCIPAL_INVESTIGATOR) |
| Kerlan-Jobe Orthopaedic Institute | Los Angeles | California | 90045 | Vernon Williams, MD Vernon Williams, MD (PRINCIPAL_INVESTIGATOR) |
| International Spine, Pain & Performance Center | Washington D.C. | District of Columbia | 20006 | Mehul Desai, MD (PRINCIPAL_INVESTIGATOR) |
| Florida Spine & Pain Specialists | Tampa | Florida | 33614 | Nomen Azeem, MD Nomen Azeem, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Dawood Sayed, MD Dawood Sayed, MD (PRINCIPAL_INVESTIGATOR) |
| Premier Pain Center | Shrewsbury | New Jersey | 07702 | Sean Li, MD (PRINCIPAL_INVESTIGATOR) |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Melinda Lawrence, MD Melinda Lawrence, MD (PRINCIPAL_INVESTIGATOR) |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Boyle Cheng, PhD Boyle Cheng, PhD (PRINCIPAL_INVESTIGATOR) Patrick DeMeo, MD (PRINCIPAL_INVESTIGATOR) Praveer Vyas, PhD (SUB_INVESTIGATOR) |