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Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura

This study has been completed.
Sponsor:
Information provided by:
Neuralieve
ClinicalTrials.gov Identifier:
NCT00449540
First received: March 18, 2007
Last updated: August 9, 2011
Last verified: July 2011

March 18, 2007
August 9, 2011
August 2006
January 2008   (final data collection date for primary outcome measure)
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment [ Time Frame: Two hours ] [ Designated as safety issue: No ]
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.
  • Percentage of patients experiencing no pain at two hours post-treatment of the first episode
  • Percentage of patients who have symptoms of nausea, vomiting, phonophobia, and photophobia two hours post treatment of the first episode.
Complete list of historical versions of study NCT00449540 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Have Symptoms of Nausea [ Time Frame: two hours post treatment ] [ Designated as safety issue: No ]
    Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
  • Percentage of Participants Who Have Symptoms Phonophobia [ Time Frame: 2 hours post treatment ] [ Designated as safety issue: No ]
    Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
  • Percentage of Participants Who Have Photophobia [ Time Frame: 2 hours post treatment ] [ Designated as safety issue: No ]
    Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
  • Percentage of patients with mild or no pain at two hours post-treatment of the first episode
  • Consistency of pain-free episodes in two out of three episodes
  • Need for rescue medication during first episode
  • Patient global assessment of relief.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Migraine With Aura
  • Device: Active Transcranial Magnetic Stimulation (TMS) Device
    Transcranial Magnetic Stimulation Device treatment
  • Device: Sham TMS Device
    Simulated Sham treatment without TMS delivery
  • Active Comparator: 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.
    Intervention: Device: Active Transcranial Magnetic Stimulation (TMS) Device
  • Sham Comparator: 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.
    Intervention: Device: Sham TMS Device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
March 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00449540
NL-2006-001
No
Ting W. Lu / President and Chief Operating Officer, Neuralieve, Inc.
Neuralieve
Not Provided
Principal Investigator: Richard B Lipton, MD Albert Einstein College of Medicine of Yeshiva University
Neuralieve
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP