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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
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 1, 2006
Primary Completion Date
January 1, 2008
Completion Date
March 1, 2008
Last Updated
August 15, 2011
201
ACTUAL participants
Active Transcranial Magnetic Stimulation (TMS) Device
DEVICE
Sham TMS Device
DEVICE
Lead Sponsor
Neuralieve
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07342296