nVNS, CBD, and SoC for Persistent Post-Traumatic Headache (NCT07624279) | Clinical Trial Compass
Not Yet RecruitingPhase 2
nVNS, CBD, and SoC for Persistent Post-Traumatic Headache
United States80 participantsStarted 2026-06-01
Plain-language summary
Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between the ages of 18 and 75 years inclusive
. Participated in competitive sports at high school level or beyond or, in the case of sports without interscholastic competition, as per investigator
. 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")
. 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
. Completed at least 80% (23 of 28 days) on 28-day baseline headache diary
. Agrees to refrain from initiating or changing the type, dosage, or frequency of any preventive headache medications whether for headache prevention or for indications other than headache that, in the opinion of the clinician may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
. Agrees to be randomized to nVNS, CBD or SoC
. Agrees to use nVNS, CBD, or SoC as intended, follow all of the requirements of the study including Follow-up Visit requirements, and record required study data in the subject e-diary
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing non-invasive vagus nerve stimulation and cannabidiol together alongside standard care for post-traumatic headache — how do those two treatments work differently from what I'm already taking, and could adding them make sense for my situation?
2Since this is a Phase 2 trial, the main goal is still establishing safety and finding the right dose range — what does that mean in practical terms for how much is really known yet about whether this combination works?
3The trial isn't recruiting yet, so there could be a wait before it opens — given where I am right now with my headaches, would it make more sense to try established treatments first while we wait, or is holding off for this trial worth considering?
4The trial is measuring reduction in moderate-to-severe headache days as its main goal — based on how many bad headache days I'm currently having, do you think I'd be a realistic candidate to discuss when enrollment does open?
5Cannabidiol can interact with other medications — are there any drugs I'm currently taking that could be a concern if I were to explore a trial that includes CBD as one of the study treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Moderate-severe headache days
Timeframe: Weeks 9-12
Trial details
NCT IDNCT07624279
SponsorAmerican Society of Pain and Neuroscience, Inc.
. 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