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

29. maj 2026 opdateret af: 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?

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cannabidiol
Medicin: Cannabidiol
Dosage titrated as per schedule
Andre navne:
  • BRC-003
Eksperimentel: Non-Invasive Vagus Nerve Stimulation
Enhed: Non-Invasive Vagus Nerve Stimulation
Two treatments to the cervical vagus nerve twice daily
Andre navne:
  • gammaCore
Eksperimentel: Standard of Care
Medicin: Standard of Care
Oral pharmacotherapy as selected by site investigator and participant

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Moderate-severe headache days
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
50% Responder Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent reduction in moderate or severe headache days
Tidsramme: 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
Tidsramme: Weeks 9-12
Change from baseline in Headache Impact Test-6
Weeks 9-12
EQ-5D-5L
Tidsramme: Weeks 9-12
Change from baseline in EQ-5D-5L
Weeks 9-12
PGIC
Tidsramme: Weeks 9-12
Patient Global Impression of Change
Weeks 9-12
PROMIS-29
Tidsramme: Week 12
Change from baseline in PROMIS-29
Week 12
Moderate-severe headache days
Tidsramme: 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
Tidsramme: 5-8
Mean reduction from baseline in number of moderate or severe headache days per 28 days during weeks 5-8
5-8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

American Society of Pain and Neuroscience, Inc.

Samarbejdspartnere

National Football League

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ASPN-NFL-US-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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