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
1 other identifier
interventional
201
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2006
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 18, 2007
CompletedFirst Posted
Study publicly available on registry
March 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
August 10, 2011
CompletedAugust 15, 2011
July 1, 2011
1.4 years
March 18, 2007
January 7, 2009
August 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
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.
Two hours
Secondary Outcomes (3)
Percentage of Participants Who Have Symptoms of Nausea
two hours post treatment
Percentage of Participants Who Have Symptoms Phonophobia
2 hours post treatment
Percentage of Participants Who Have Photophobia
2 hours post treatment
Study Arms (2)
Active Transcranial Magnetic Stimulation (TMS) Device
ACTIVE COMPARATORBoth 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 COMPARATORBoth 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.
Interventions
Transcranial Magnetic Stimulation Device treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuralievelead
Study Sites (14)
San Francisco Headache Clinic
San Francisco, California, 94109, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Diamond Headache Clinic, LTD
Chicago, Illinois, 60614, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Westside Family Medical Center
Kalamazoo, Michigan, 49009, United States
Clinvest, Inc.
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Kirchner Headache Clinic
Omaha, Nebraska, 68144, United States
Montefiore Headache Center
The Bronx, New York, 10461, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
The Innovative Clinical Research Center
Alexandria, Virginia, 22304, United States
Swedish Headache Center
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 20206581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cynthia Merrell
- Organization
- Neuralieve
Study Officials
- PRINCIPAL INVESTIGATOR
Richard B Lipton, MD
Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2007
First Posted
March 20, 2007
Study Start
August 1, 2006
Primary Completion
January 1, 2008
Study Completion
March 1, 2008
Last Updated
August 15, 2011
Results First Posted
August 10, 2011
Record last verified: 2011-07