Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
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.
In the Lead-in Phase participants will use a Personal Digital Assistant (PDA) to keep an
 electronic diary of their migraine episodes. During a migraine episode, as well as the time
 in between headaches, the PDA prompts the participant to answer questions. Each evening, the
 participant will place the PDA into an electronic telephone cradle, and the information will
 be transmitted electronically from the PDA to the data management team to assess the
 frequency of migraine episodes and participant proficiency with the PDA. During this one
 month period, the participant must experience at least one migraine with aura episode to
 enter the Treatment Phase.

 After one month, the participant will return to the clinic with their PDA and will enter the
 Treatment Phase to be randomized to either the TMS only group or the Sham stimulation only
 group. Participant will enter information into the PDA for three migraine auras treated or
 three months, which ever comes first.
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.