nVNS, CBD, and SoC for Persistent Post-Traumatic Headache
NCT07624279 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-06-03
Summary
Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?
Conditions
- Persistent Post Traumatic Headache
Interventions
- DEVICE
-
Non-Invasive Vagus Nerve Stimulation
Two treatments to the cervical vagus nerve twice daily
- DRUG
-
Cannabidiol
Dosage titrated as per schedule
- DRUG
-
Standard of Care
Oral pharmacotherapy as selected by site investigator and participant
Sponsors & Collaborators
-
National Football League
collaborator OTHER -
American Society of Pain and Neuroscience, Inc.
lead OTHER
Principal Investigators
-
Nathaniel M Schuster, MD · University of California, San Diego
-
Erika A Petersen, MD · University of Arkansas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2027-07-31
- Completion
- 2028-07-01
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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