Evaluating Efficacy and Safety of Transcranial TMS Stimulation (TMS) for the Preemptive Treatment of Migraine With Aura

2014-08-27 03:39:32 | BioPortfolio


Assess safety and efficacy of TMS for the treatment of migraine with aura

The hypothesis is that TMS treatments delivered to the occipital lobe of the brain (visual cortex) can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine headache. A pair of transcranial TMS treatments at <1 Tesla for ~500 microseconds output of the TMS stimulator approximately 30 seconds apart may stop the aura and prevent the subsequent headache.


In the Lead-in Phase patients will use a 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 patient to answer questions. Each evening, the patient 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 aura with migraine episodes and patient proficiency with the PDA. During this one month period, the patient must experience at least one migraine episode to enter the Treatment Phase.

After one month, the patients 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. Patients will enter information into the PDA for three auras treated or three months, which ever comes first.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Migraine With Aura


TMS Device


San Francisco Headache Clinic
San Francisco
United States


Active, not recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:39:32-0400

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