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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
201
Transcranial Magnetic Stimulation Device treatment
Simulated Sham treatment without TMS delivery
San Francisco Headache Clinic
San Francisco, California, United States
Mile High Research Center
Denver, Colorado, United States
Diamond Headache Clinic, LTD
Chicago, Illinois, United States
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.
Time frame: Two hours
Percentage of Participants Who Have Symptoms of Nausea
Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Time frame: two hours post treatment
Percentage of Participants Who Have Symptoms Phonophobia
Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Time frame: 2 hours post treatment
Percentage of Participants Who Have Photophobia
Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Time frame: 2 hours post treatment
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Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Westside Family Medical Center
Kalamazoo, Michigan, United States
Clinvest, Inc.
Springfield, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Kirchner Headache Clinic
Omaha, Nebraska, United States
Montefiore Headache Center
The Bronx, New York, United States
The Ohio State University
Columbus, Ohio, United States
...and 4 more locations