Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Epilepsy; Migraine with Aura
Intervention: Active Transcranial Magnetic Stimulation (TMS) Device; Sham TMS Device
Intervention description: Transcranial Magnetic Stimulation Device treatment; Simulated Sham treatment without TMS delivery
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine with aura; aura; TMS

Summary:

      Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of
      migraine with aura

      The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop
      or interrupt the spreading cortical brain activity that causes or contributes to the migraine
      headache. Two TMS treatments at an intensity of <1 Tesla for ~500 microseconds, approximately
      30 seconds apart, may stop the aura and prevent the subsequent headache.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 65 years

          -  Will comply with requirements of the protocol

          -  Have a consistent history of migraine with visual aura of at least one year

             •>30% of episodes have a visual aura preceding headaches

          -  Approximately 90% of the time have moderate or severe headaches following their aura

          -  Fulfills the International Classification of Headache Disorders, 2nd Edition(ICHD-II)
             criteria(for migraine headache with aura after administration of a clinical interview
             by study personnel

          -  Has a history of 1-8 migraine headache episodes with aura per month

          -  Can differentiate a migraine headache from other types of headaches

          -  Participant is post-menopausal, sterilized, not breastfeeding, her pregnancy test is
             negative

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Routinely experiences any other type of headache that would confound discrimination
             from migraine headache with aura

          -  Have migraine with prolonged aura > 60 minutes

          -  Have headaches due to other underlying pathology

          -  Have headaches related to head or neck trauma

          -  Overuse headache medications:

          -  Has an intracranial metallic or Transcranial Magnetic Stimulation (TMS) implant or
             other metallic implants

          -  Has cardiac pacemaker or any other implanted electronic device

          -  Has any known history of alcohol abuse, drug dependency, or significant psychiatric
             illness in the previous 12 months

          -  Having any medical condition, including but not limited to: clinically significant
             renal or hepatic disease; uncontrolled hypertension; clinically significant coronary
             vascular disease not stable for the past 6 months; personal or family history of
             seizures or taking medications for seizures or drugs that may lower seizure threshold,
             cerebral vascular ischemia; infarct; hemorrhage, or other central nervous system
             disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis); unstable metabolic
             disease, hypoglycemia or diabetes; malignancy within the past 5 years excluding
             cutaneous basal cell carcinoma; tuberculosis

          -  Has participated in any other investigational study within the previous 30 days.

          -  Cannot place the device within 1 cm of the scalp.