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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.
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
San Francisco Headache Clinic
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:39:32-0400
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A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
Recurrent unilateral pulsatile headaches, not preceded or accompanied by an aura, in attacks lasting 4-72 hours. It is characterized by PAIN of moderate to severe intensity; aggravated by physical activity; and associated with NAUSEA and / or PHOTOPHOBIA and PHONOPHOBIA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
The decrease in neuronal activity (related to a decrease in metabolic demand) extending from the site of cortical stimulation. It is believed to be responsible for the decrease in cerebral blood flow that accompanies the aura of MIGRAINE WITH AURA. (Campbell's Psychiatric Dictionary, 8th ed.)
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