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

NCT00449540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2011-08-15

Study results available
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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.

Conditions

  • Migraine With Aura

Interventions

DEVICE

Active Transcranial Magnetic Stimulation (TMS) Device

Transcranial Magnetic Stimulation Device treatment

DEVICE

Sham TMS Device

Simulated Sham treatment without TMS delivery

Sponsors & Collaborators

  • Neuralieve

    lead INDUSTRY

Principal Investigators

  • Richard B Lipton, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-01-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00449540 on ClinicalTrials.gov