Clinical trial NCT00449540: Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With Aura
Keywords: Migraine with aura
aura
TMS
Lead sponsor: Neuralieve
Sponsor class: INDUSTRY
First posted: 2007-03-20
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
timeFrame: Two hours
Secondary outcomes:
measure: Percentage of Participants Who Have Symptoms of Nausea
timeFrame: two hours post treatment
measure: Percentage of Participants Who Have Symptoms Phonophobia
timeFrame: 2 hours post treatment
measure: Percentage of Participants Who Have Photophobia
timeFrame: 2 hours post treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Headache Clinic
state: California
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Chicago
country: United States
facility: Diamond Headache Clinic, LTD
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Springfield
country: United States
facility: Clinvest, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Omaha
country: United States
facility: Kirchner Headache Clinic
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Headache Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Alexandria
country: United States
facility: The Innovative Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Headache Center
state: Washington
Study officials:
affiliation: Albert Einstein College of Medicine
name: Richard B Lipton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.