Phase 3
N=267
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Migraine With Aura
Bottom Line
View on ClinicalTrials.gov: NCT00449540 ↗Enrolled (actual)
267
Serious AEs
0.3%
Results posted
Aug 2011
Primary outcome: Primary: Percentage of Participants Experiencing no Pain at Two Hours Post-treatment — 39; 22 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Active Transcranial Magnetic Stimulation (TMS) Device (Device); Sham TMS Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neuralieve
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing no Pain at Two Hours Post-treatment |
39; 22 | — |
| SECONDARY Percentage of Participants Who Have Symptoms of Nausea |
38; 40 | — |
| SECONDARY Percentage of Participants Who Have Symptoms Phonophobia |
57; 63 | — |
| SECONDARY Percentage of Participants Who Have Photophobia |
70; 78 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00449540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.