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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Preemptiv

Brief 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 Summary:

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.


Sponsor: Neuralieve

Current Primary Outcome: Percentage of Participants Experiencing no Pain at Two Hours Post-treatment [ Time Frame: Two hours ]

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.


Original Primary Outcome:

  • Percentage of patients experiencing no pain at two hours post-treatment of the first episode
  • Percentage of patients who have symptoms of nausea, vomiting, phonophobia, and photophobia two hours post treatment of the first episode.


Current Secondary Outcome:

  • Percentage of Participants Who Have Symptoms of Nausea [ Time Frame: two hours post treatment ]
    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.
  • Percentage of Participants Who Have Symptoms Phonophobia [ Time Frame: 2 hours post treatment ]
    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.
  • Percentage of Participants Who Have Photophobia [ Time Frame: 2 hours post treatment ]
    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.


Original Secondary Outcome:

  • Percentage of patients with mild or no pain at two hours post-treatment of the first episode
  • Consistency of pain-free episodes in two out of three episodes
  • Need for rescue medication during first episode
  • Patient global assessment of relief.


Information By: Neuralieve

Dates:
Date Received: March 18, 2007
Date Started: August 2006
Date Completion:
Last Updated: August 9, 2011
Last Verified: July 2011