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

August 9, 2011 updated by: Neuralieve

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • San Francisco Headache Clinic
    • Colorado
      • Denver, Colorado, United States, 80218
        • Mile High Research Center
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Diamond Headache Clinic, LTD
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest, Inc.
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Kirchner Headache Clinic
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Headache Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Headache Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Neuroscience Group
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • The Innovative Clinical Research Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Active Transcranial Magnetic Stimulation (TMS) Device
Transcranial Magnetic Stimulation Device treatment
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.
Device: Sham TMS Device
Simulated Sham treatment without TMS delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
Time Frame: Two hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Have Symptoms of Nausea
Time Frame: two hours post treatment
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.
two hours post treatment
Percentage of Participants Who Have Symptoms Phonophobia
Time Frame: 2 hours post treatment
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.
2 hours post treatment
Percentage of Participants Who Have Photophobia
Time Frame: 2 hours post treatment
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.
2 hours post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralieve

Investigators

  • Principal Investigator: Richard B Lipton, MD, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 18, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL-2006-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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