NCT00449540

Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Neuralieve · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Migraine With Aura

Interventions

Type	Name	Description
DEVICE	Active Transcranial Magnetic Stimulation (TMS) Device	Transcranial Magnetic Stimulation Device treatment
DEVICE	Sham TMS Device	Simulated Sham treatment without TMS delivery

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-01-01
• Completion: 2008-03-01
• First posted: 2007-03-20
• Last updated: 2011-08-15
• Results posted: 2011-08-10

Locations

14 sites across 1 country: United States