Migraine With Aura
Conditions
Keywords
Migraine with aura, aura, TMS
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.
Interventions
DEVICEActive Transcranial Magnetic Stimulation (TMS) Device
Transcranial Magnetic Stimulation Device treatment
DEVICESham TMS Device
Simulated Sham treatment without TMS delivery
Sponsors
Neuralieve
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing no Pain at Two Hours Post-treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Have Symptoms of Nausea | two hours post treatment | 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. |
| Percentage of Participants Who Have Symptoms Phonophobia | 2 hours post treatment | 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. |
| Percentage of Participants Who Have Photophobia | 2 hours post treatment | 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. |
Countries
United States
Participant flow
Pre-assignment details
267 participants enrolled in the 30 day Lead-In phase as described. 66 participants did not experience migraine in the 30 days allotted and therefore were not moved to the treatment phase. 201 participants were moved to the treatment phase
Participants by arm
| Arm | Count |
|---|---|
| Active Transcranial Magnetic Stimulation (TMS) Device Active Transcranial Magnetic Stimulation Device Treatment | 102 |
| Sham TMS Device Simulated Sham treatment without TMS | 99 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Pretreatment Phase | No migraine experienced | 66 | 0 | 0 |
| Treatment Phase | did not experience or treat migraine | 0 | 20 | 17 |
Baseline characteristics
| Characteristic | Sham TMS Device | Active Transcranial Magnetic Stimulation (TMS) Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants | 102 Participants | 201 Participants |
| Age Continuous | 40.1 years STANDARD_DEVIATION 10.83 | 38.8 years STANDARD_DEVIATION 11.2 | 39.4 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 99 participants | 102 participants | 201 participants |
| Sex: Female, Male Female | 78 Participants | 80 Participants | 158 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 102 | 2 / 99 | 12 / 102 | 8 / 99 |
| serious Total, serious adverse events | 0 / 102 | 0 / 99 | 1 / 102 | 0 / 99 |
Outcome results
Primary
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.
Time frame: Two hours
Population: Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS) Device | Percentage of Participants Experiencing no Pain at Two Hours Post-treatment | 39 percentage of participants |
| Sham TMS Device | Percentage of Participants Experiencing no Pain at Two Hours Post-treatment | 22 percentage of participants |
Secondary
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.
Time frame: 2 hours post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS) Device | Percentage of Participants Who Have Photophobia | 70 Percentage of participants |
| Sham TMS Device | Percentage of Participants Who Have Photophobia | 78 Percentage of participants |
Secondary
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.
Time frame: two hours post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS) Device | Percentage of Participants Who Have Symptoms of Nausea | 38 percentage of participants |
| Sham TMS Device | Percentage of Participants Who Have Symptoms of Nausea | 40 percentage of participants |
Secondary
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.
Time frame: 2 hours post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS) Device | Percentage of Participants Who Have Symptoms Phonophobia | 57 Percentage of Participants |
| Sham TMS Device | Percentage of Participants Who Have Symptoms Phonophobia | 63 Percentage of Participants |