Migraine With Aura Clinical Trial
Official title:
Phase III Randomized Double-Blind Parallel Group Sham-Controlled Study Evaluating the Efficacy and Safety of Non-invasive Non-repetitive Transcranial Magnetic Stimulation (TMS) for the Acute Preemptive Treatment of the Aura Phase of Migraine Headache
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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