Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Overview

Información sobre este estudio

The study sponsor has developed a non-invasive treatment for reducing migraine pain. The Theranova Migraine Treatment System uses electrical stimulation applied to the skin.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • 18-100 years, inclusive.
  • Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria.
  • 4-14 migraine days per month.
  • Ability to provide informed consent.
  • Demonstrates no contraindication to the use of electrical nerve stimulation.
  • Capable and willing to follow all study-related procedures.

Exclusion Criteria: 

  • Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period.
  • Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria.
  • Any medical condition that would, in the opinion of the investigator, make the subject ineligible.
  • Has received botulinum toxin injections within the past 3 months.
  • Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant.
  • Use of investigational drug/device therapy within the past 4 weeks.
  • Deemed unsuitable for enrollment in study by the investigator based on subjects'' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy).
  • No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Amaal Starling, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20509614

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