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nVNS, CBD, and SoC for Persistent Post-Traumatic Headache

29 mei 2026 bijgewerkt door: American Society of Pain and Neuroscience, Inc.

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

Do cannabidiol (CBD) or vagus nerve stimulation reduce the frequency of persistent post-traumatic headache more than traditional oral headache medications?

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Arizona
      • Scottsdale, Arizona, Verenigde Staten, 85054
    • California
      • Los Angeles, California, Verenigde Staten, 90045
    • District of Columbia
      • Washington D.C., District of Columbia, Verenigde Staten, 20006
        • International Spine, Pain & Performance Center
        • Hoofdonderzoeker:
          • Mehul Desai, MD
        • Contact:
    • Florida
      • Tampa, Florida, Verenigde Staten, 33614
        • Florida Spine & Pain Specialists
        • Hoofdonderzoeker:
          • Nomen Azeem, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Medical Center
        • Hoofdonderzoeker:
          • Dawood Sayed, MD
        • Contact:
    • New Jersey
      • Shrewsbury, New Jersey, Verenigde Staten, 07702
        • Premier Pain Center
        • Hoofdonderzoeker:
          • Sean Li, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • Allegheny General Hospital
        • Hoofdonderzoeker:
          • Boyle Cheng, PhD
        • Hoofdonderzoeker:
          • Patrick DeMeo, MD
        • Contact:
        • Onderonderzoeker:
          • Praveer Vyas, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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 baseline headache diary
  6. 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.)
  7. Agrees to be randomized to nVNS, CBD or SoC
  8. 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
  9. Able to provide written informed consent

EXCLUSION CRITERIA

  1. Body weight at screening of less than 40 kg
  2. Other severe pain condition (e.g., cancer pain or trigeminal neuralgia) that, in the discretion of the investigator, may confound the study assessments
  3. 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
  4. Psychiatric, substance abuse, or cognitive disorder and/or behavioral problems that, in the opinion of the investigator, may interfere with the study.
  5. 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
  6. Currently takes prescription opioids more than 4 days per month for any indication
  7. 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
  8. Currently implanted with a cardiac defibrillator
  9. Allergy to CBD or other components of Cannabis sativa L. (including hemp or cannabis)
  10. Previously used gammaCore or high-dose CBD (>100mg/day) for PPTH
  11. Used medical marijuana, cannabis, hemp or CBD-based product within 30 days prior to the study
  12. Unwilling to discontinue use of medical marijuana, cannabis, hemp or CBD-based product during the study
  13. Patients using medications that can interact with the study drug and/or its safety profile throughout the study and for at least five half-lives after the last dose of investigational product, including clobazam and valproic acid and other drugs according to the drug-drug interaction (DDI) risks as described in the Epidiolex USPI.
  14. Patients who are pregnant, breastfeeding, or not using acceptable methods of contraception during the course of the study and for three months thereafter.
  15. Male patient's partner is of childbearing potential; unless willing to ensure that they (male patients) or their partner(s) are using acceptable methods of contraception during the course of the study and for three months thereafter.
  16. Participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
  17. A relative of or an employee of the Investigator or the clinical study site
  18. Presence of any implantable device that may interfere or interact with gammaCore, any history of cardiac arrhythmias or conduction defects, and any other medical history that, in the opinion of the investigator and/or based on the labeling of gammaCore, may increase the risk of using the gammaCore device.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cannabidiol
Geneesmiddel: Cannabidiol
Dosage titrated as per schedule
Andere namen:
  • BRC-003
Experimenteel: Non-Invasive Vagus Nerve Stimulation
Apparaat: Non-Invasive Vagus Nerve Stimulation
Two treatments to the cervical vagus nerve twice daily
Andere namen:
  • gammaCore
Experimenteel: Standard of Care
Geneesmiddel: Standard of Care
Oral pharmacotherapy as selected by site investigator and participant

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Moderate-severe headache days
Tijdsspanne: Weeks 9-12
Mean reduction from baseline in number of moderate or severe headache days per 28 days during weeks 9-12
Weeks 9-12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
50% Responder Rate
Tijdsspanne: Weeks 9-12
Percentage of participants who report at least a 50% reduction in the number of moderate or severe headache days per 28 days during the last 4 weeks versus the 4 week baseline period
Weeks 9-12
Headache days
Tijdsspanne: Weeks 9-12
Mean reduction from baseline in number of headache days per 28 days during weeks 9-12
Weeks 9-12
Acute headache medication days
Tijdsspanne: Weeks 9-12
Mean reduction from baseline in number of days that acute medication was used per 28 days during weeks 9-12
Weeks 9-12

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent reduction in moderate or severe headache days
Tijdsspanne: Weeks 9-12
Mean percent reduction from baseline in moderate or severe headache days per 28 days during weeks 9-12
Weeks 9-12
HIT-6
Tijdsspanne: Weeks 9-12
Change from baseline in Headache Impact Test-6
Weeks 9-12
EQ-5D-5L
Tijdsspanne: Weeks 9-12
Change from baseline in EQ-5D-5L
Weeks 9-12
PGIC
Tijdsspanne: Weeks 9-12
Patient Global Impression of Change
Weeks 9-12
PROMIS-29
Tijdsspanne: Week 12
Change from baseline in PROMIS-29
Week 12
Moderate-severe headache days
Tijdsspanne: 1-4
Mean reduction from baseline in number of moderate or severe headache days per 28 days during weeks 1-4
1-4
Moderate-severe headache days
Tijdsspanne: 5-8
Mean reduction from baseline in number of moderate or severe headache days per 28 days during weeks 5-8
5-8

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

American Society of Pain and Neuroscience, Inc.

Medewerkers

National Football League

Onderzoekers

  • Hoofdonderzoeker: Nathaniel M Schuster, MD, University of California, San Diego
  • Hoofdonderzoeker: Erika A Petersen, MD, University of Arkansas

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 juli 2027

Studie voltooiing (Geschat)

1 juli 2028

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ASPN-NFL-US-1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

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