Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

29. mai 2026 oppdatert av: 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?

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85054
        • Mayo Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Natalie Strand, MD
    • California
      • Los Angeles, California, Forente stater, 90045
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20006
        • International Spine, Pain & Performance Center
        • Hovedetterforsker:
          • Mehul Desai, MD
        • Ta kontakt med:
    • Florida
      • Tampa, Florida, Forente stater, 33614
        • Florida Spine & Pain Specialists
        • Hovedetterforsker:
          • Nomen Azeem, MD
        • Ta kontakt med:
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Medical Center
        • Hovedetterforsker:
          • Dawood Sayed, MD
        • Ta kontakt med:
    • New Jersey
      • Shrewsbury, New Jersey, Forente stater, 07702
        • Premier Pain Center
        • Hovedetterforsker:
          • Sean Li, MD
        • Ta kontakt med:
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Cleveland Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Melinda Lawrence, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny General Hospital
        • Hovedetterforsker:
          • Boyle Cheng, PhD
        • Hovedetterforsker:
          • Patrick DeMeo, MD
        • Ta kontakt med:
        • Underetterforsker:
          • Praveer Vyas, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cannabidiol
Legemiddel: Cannabidiol
Dosage titrated as per schedule
Andre navn:
  • BRC-003
Eksperimentell: Non-Invasive Vagus Nerve Stimulation
Enhet: Non-Invasive Vagus Nerve Stimulation
Two treatments to the cervical vagus nerve twice daily
Andre navn:
  • gammaCore
Eksperimentell: Standard of Care
Legemiddel: Standard of Care
Oral pharmacotherapy as selected by site investigator and participant

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

American Society of Pain and Neuroscience, Inc.

Samarbeidspartnere

National Football League

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ASPN-NFL-US-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere