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

Phase 3

Completed

Interventions: Device: Active Transcranial Magnetic Stimulation (TMS) Device
Device: Sham TMS Device

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 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.

Recruitment & Eligibility

Inclusion Criteria

18 - 65 years
Will comply with requirements of the protocol
Have a consistent history of migraine with visual aura of at least one year

•>30% of episodes have a visual aura preceding headaches
Approximately 90% of the time have moderate or severe headaches following their aura
Fulfills the International Classification of Headache Disorders, 2nd Edition(ICHD-II) criteria(for migraine headache with aura after administration of a clinical interview by study personnel
Has a history of 1-8 migraine headache episodes with aura per month
Can differentiate a migraine headache from other types of headaches
Participant is post-menopausal, sterilized, not breastfeeding, her pregnancy test is negative

Exclusion Criteria

Women who are pregnant or breastfeeding
Routinely experiences any other type of headache that would confound discrimination from migraine headache with aura
Have migraine with prolonged aura > 60 minutes
Have headaches due to other underlying pathology
Have headaches related to head or neck trauma
Overuse headache medications:
Has an intracranial metallic or Transcranial Magnetic Stimulation (TMS) implant or other metallic implants
Has cardiac pacemaker or any other implanted electronic device
Has any known history of alcohol abuse, drug dependency, or significant psychiatric illness in the previous 12 months
Having any medical condition, including but not limited to: clinically significant renal or hepatic disease; uncontrolled hypertension; clinically significant coronary vascular disease not stable for the past 6 months; personal or family history of seizures or taking medications for seizures or drugs that may lower seizure threshold, cerebral vascular ischemia; infarct; hemorrhage, or other central nervous system disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis); unstable metabolic disease, hypoglycemia or diabetes; malignancy within the past 5 years excluding cutaneous basal cell carcinoma; tuberculosis
Has participated in any other investigational study within the previous 30 days.
Cannot place the device within 1 cm of the scalp.

Arm && Interventions

Group	Intervention	Description
Active Transcranial Magnetic Stimulation (TMS) Device	Active Transcranial Magnetic Stimulation (TMS) Device	Both arms of participants receive identical looking devices and were instructed use the same treatment protocol. Participants in each group were instructed to treat with the device within one hour of onset of migraine aura.
Sham TMS Device	Sham TMS Device	Both arms of participants receive identical looking devices and were instructed use the same treatment protocol. Participants in each group were instructed to treat with the device within one hour of onset of migraine aura.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Have Symptoms of Nausea	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	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	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.

Locations (14): Diamond Headache Clinic, LTD
🇺🇸
Chicago, Illinois, United States
Westside Family Medical Center
🇺🇸
Kalamazoo, Michigan, United States
Mercy Health Research
🇺🇸
St. Louis, Missouri, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
San Francisco Headache Clinic
🇺🇸
San Francisco, California, United States
Swedish Headache Center
🇺🇸
Seattle, Washington, United States
Mile High Research Center
🇺🇸
Denver, Colorado, United States
Nashville Neuroscience Group
🇺🇸
Nashville, Tennessee, United States
Michigan Head Pain & Neurological Institute
🇺🇸
Ann Arbor, Michigan, United States
Clinvest, Inc.
🇺🇸
Springfield, Missouri, United States
The Innovative Clinical Research Center
🇺🇸
Alexandria, Virginia, United States
Kirchner Headache Clinic
🇺🇸
Omaha, Nebraska, United States
Montefiore Headache Center
🇺🇸
Bronx, New York, United States
Jefferson Headache Center
🇺🇸
Philadelphia, Pennsylvania, United States