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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 201
- Locations
- 28
- Primary Endpoint
- Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Participants Who Have Symptoms of Nausea(two hours post treatment)
- Percentage of Participants Who Have Symptoms Phonophobia(2 hours post treatment)
- Percentage of Participants Who Have Photophobia(2 hours post treatment)