Status:
COMPLETED
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Lead Sponsor:
Neuralieve
Conditions:
Migraine With Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
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 headache...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00449540
Start Date
August 1 2006
End Date
March 1 2008
Last Update
August 15 2011
Active Locations (14)
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1
San Francisco Headache Clinic
San Francisco, California, United States, 94109
2
Mile High Research Center
Denver, Colorado, United States, 80218
3
Diamond Headache Clinic, LTD
Chicago, Illinois, United States, 60614
4
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104