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Migraine With AuraPhase 3NCT00449540

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

A Phase 3 study testing Active Transcranial Magnetic Stimulation (TMS) Device in people with Migraine With Aura, run by Neuralieve at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine With Aura
What is being tested?
Active Transcranial Magnetic Stimulation (TMS) Device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
201 participants
Where
14 sitesUnited States
Study dates
Aug 2006to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • The Innovative Clinical Research Center

    Alexandria, Virginia, 22304

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Diamond Headache Clinic, LTD

    Chicago, Illinois, 60614

  • The Ohio State University

    Columbus, Ohio, 43210

  • Mile High Research Center

    Denver, Colorado, 80218

  • Westside Family Medical Center

    Kalamazoo, Michigan, 49009

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203

  • Kirchner Headache Clinic

    Omaha, Nebraska, 68144

  • Jefferson Headache Center

    Philadelphia, Pennsylvania, 19107

  • San Francisco Headache Clinic

    San Francisco, California, 94109

  • Swedish Headache Center

    Seattle, Washington, 98104

  • Clinvest, Inc.

    Springfield, Missouri, 65807

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Montefiore Headache Center

    The Bronx, New York, 10461

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Active Transcranial Magnetic Stimulation (TMS) Device, Sham TMS Device
Keywords
Migraine with aura, aura, TMS
Medical subject headings
Migraine with Aura, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Transcranial Magnetic Stimulation (TMS) DeviceDevice

    Transcranial Magnetic Stimulation Device treatment

  • Sham TMS DeviceDevice

    Simulated Sham treatment without TMS delivery

Study groups in NCT00449540
Study groupRoleWhat they receive
Active Transcranial Magnetic Stimulation (TMS) DeviceActive comparatorBoth 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.
Receives: Device: Active Transcranial Magnetic Stimulation (TMS) Device
Sham TMS DeviceSham comparatorBoth 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.
Receives: Device: Sham TMS Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing no Pain at Two Hours Post-treatment

    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.

    Measured: Two hours

Secondary outcomes (3)

  1. Percentage of Participants Who Have Symptoms of Nausea

    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.

    Measured: two hours post treatment

  2. Percentage of Participants Who Have Symptoms Phonophobia

    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.

    Measured: 2 hours post treatment

  3. Percentage of Participants Who Have Photophobia

    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.

    Measured: 2 hours post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2007 (estimated)
  2. Study startAug 2006
  3. Primary completionJan 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00449540
Sponsor's protocol ID
NL-2006-001
Status last verified
Jul 2011
First submitted
18 Mar 2007
Last updated
15 Aug 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 20206581

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Active Transcranial Magnetic Stimulation (TMS) Device in people with Migraine With Aura, run by Neuralieve at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing no Pain at Two Hours Post-treatment (time frame: Two hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00449540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.

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