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

29 de mayo de 2026 actualizado por: 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?

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Erika A Petersen
  • Número de teléfono: 501-686-5270
  • Correo electrónico: eapetersen@uams.edu

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85054
        • Mayo Clinic
        • Contacto:
        • Investigador principal:
          • Natalie Strand, MD
    • California
      • Los Angeles, California, Estados Unidos, 90045
        • Kerlan-Jobe Orthopaedic Institute
        • Contacto:
        • Investigador principal:
          • Vernon Williams, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20006
        • International Spine, Pain & Performance Center
        • Investigador principal:
          • Mehul Desai, MD
        • Contacto:
    • Florida
      • Tampa, Florida, Estados Unidos, 33614
        • Florida Spine & Pain Specialists
        • Investigador principal:
          • Nomen Azeem, MD
        • Contacto:
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • University of Kansas Medical Center
        • Investigador principal:
          • Dawood Sayed, MD
        • Contacto:
    • New Jersey
      • Shrewsbury, New Jersey, Estados Unidos, 07702
        • Premier Pain Center
        • Investigador principal:
          • Sean Li, MD
        • Contacto:
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • University Hospitals Cleveland Medical Center
        • Contacto:
        • Investigador principal:
          • Melinda Lawrence, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Allegheny General Hospital
        • Investigador principal:
          • Boyle Cheng, PhD
        • Investigador principal:
          • Patrick DeMeo, MD
        • Contacto:
        • Sub-Investigador:
          • Praveer Vyas, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cannabidiol
Droga: Cannabidiol
Dosage titrated as per schedule
Otros nombres:
  • BRC-003
Experimental: Non-Invasive Vagus Nerve Stimulation
Dispositivo: Non-Invasive Vagus Nerve Stimulation
Two treatments to the cervical vagus nerve twice daily
Otros nombres:
  • gammaCore
Experimental: Standard of Care
Droga: Standard of Care
Oral pharmacotherapy as selected by site investigator and participant

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Moderate-severe headache days
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
50% Responder Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

American Society of Pain and Neuroscience, Inc.

Colaboradores

National Football League

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de julio de 2027

Finalización del estudio (Estimado)

1 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2026

Publicado por primera vez (Actual)

3 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ASPN-NFL-US-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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