Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
NCT ID: NCT00449540
Last Updated: 2011-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2006-08-31
2008-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Active Transcranial Magnetic Stimulation (TMS) Device
Transcranial Magnetic Stimulation Device treatment
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.
Sham TMS Device
Simulated Sham treatment without TMS delivery
Interventions
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Active Transcranial Magnetic Stimulation (TMS) Device
Transcranial Magnetic Stimulation Device treatment
Sham TMS Device
Simulated Sham treatment without TMS delivery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Neuralieve
INDUSTRY
Responsible Party
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Neuralieve, Inc.
Principal Investigators
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Richard B Lipton, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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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
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
Jefferson Headache Center
Philadelphia, Pennsylvania, United States
Nashville Neuroscience Group
Nashville, Tennessee, United States
The Innovative Clinical Research Center
Alexandria, Virginia, United States
Swedish Headache Center
Seattle, Washington, United States
Countries
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References
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Lipton RB, Dodick DW, Silberstein SD, Saper JR, Aurora SK, Pearlman SH, Fischell RE, Ruppel PL, Goadsby PJ. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial. Lancet Neurol. 2010 Apr;9(4):373-80. doi: 10.1016/S1474-4422(10)70054-5. Epub 2010 Mar 4.
Other Identifiers
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NL-2006-001
Identifier Type: -
Identifier Source: org_study_id
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