CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
Active Transcranial Magnetic Stimulation (TMS) Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00449540
NCT00449540Phase 3Completed
CompareCT.gov

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

Neuralieve·interventional·Posted Mar 20, 2007·Updated Aug 15, 2011

In Brief

A Phase 3 clinical trial evaluating Active Transcranial Magnetic Stimulation (TMS) Device and Sham TMS Device for Migraine With Aura. Completed, enrolled 201 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine With Aura
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 20, 2007
Enrollment StartAug 1, 2006
Primary CompletionJan 1, 2008
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.3 years ago

Interventions

Active Transcranial Magnetic Stimulation (TMS) Devicedevice

Transcranial Magnetic Stimulation Device treatment

Sham TMS Devicedevice

Simulated Sham treatment without TMS delivery