After three months of Device use, the average Total Monthly Headache Pain Score compared to the average derived from the Pre-use Baseline Period (1 month). This is calculated by adding the cumulative maximum pain scores for all days the subject had a headache, as noted as the maximum daily headache pain score on a scale of 1 (lowest pain)-10 (highest pain) for each headache day as reported by the subject in their daily headache diary. Each month was counted as 28 days. Therefore, the total possible score for each month was 28-280. A negative number indicates a reduction in pain score.

A patient's Pre-device use Baseline Period mood score from the Beck Depression Index is compared with those at the end of the 3 month Device use period. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, with each of the 21 items, rated on a 4-point scale (0-3). The total scores rage from 0-63. The higher the score the more depressed. Mood scores are assessed for: decline, no change, or an improvement. A negative score indicates improvement in mood.

The purpose of this study endpoint is to verify, using the Berg Balance test, the absence of change in material dizziness (with the associated risk of falls) as a consequence of using the Device. The test consists of 14 balance- related tasks ranging from standing up from a sitting position to standing on one foot. Each task is graded from 0 - 4, and the final measure is the sum from all elements of the Test: • 41-56 = low risk of fall • 21-40 = medium risk of fall • 0-20 = high risk of fall. Possible scores range from 0-56. Scores of zero indicate no change in balance.

A patient's Pre-use Baseline Period cognitive speed scores, using the Digit Symbol Coding assessment, will be compared with those at the end of the Device use period. The Digit-Symbol Subtest of the WAIS-III, is a timed pencil-and-paper task that measures processing speed and visual-motor coordination. It involves matching symbols to numbers using a key, with the goal of completing as many correct matches as possible within a 120-second time limit. The number of correct matches completed is counted. The lowest possible count is 0 (zero correct matches). The higher the number of correct matches completed, the better the cognitive speed of the participant. Cognitive speed will be assessed for: a decline, no change, or an improvement. A positive number indicates improvement.

A patient's Pre-use Baseline Period memory scores, using Short Term memory test (an old/new paradigm for face recognition) are compared with those at the end of the 3-month Device use period. This assessment was created by the study Neuropsychologist where participants were shown faces at baseline then shown another set which included a subset then had seen before and had to say if they had seen them before later during the visit (to test short term memory). Scores range from 0-10. Higher scores indicate better short term memory. Memory scores were assessed for: a decline, no change, or an improvement from baseline to the end of treatment month 3. A negative score indicates improvement.

This measures counts the number of times abortive medications are taken. The baseline count is subtracted from the third month count. A negative number indicates a reduction in abortive medications used. The greater the negative number, the more reduced the use of abortive medications.

Participants (episodic migraineurs) self-administered twice-daily partially active treatments for 12 weeks

The description of this treatment is a standardized partially-active neuromodulation waveform delivered twice daily was used for the first 20 participants randomized to the placebo group at all Study sites.

While the participants in this group were supposed to have received a fully-inactive waveform, their devices were found to be delivering an unintended partially-active treatment. This was discovered well after the study had begun. As their results did not represent use of a true (i.e., fully inactive) device, these participants were separated from the main placebo group and followed for safety only for the duration of the study.

Total of all reporting groups

Only participants with data for this baseline analysis measure were included in this analysis. Disease duration was not collected for two(2) BID Active, one (1) BID Placebo, and three (3) BID Partially-Active Placebo participants.

Only participants with data reported for this baseline measure are included in the analysis. Education data was not collected for four (4) BID Active and three (3) BID Placebo participants.

The number of days with a migraine headache reported during the 28-day baseline period, based on a headache diary

Only participants with data reported for this baseline measure are included in the analysis. Data is missing for this baseline measure due to the original headache diaries being either inaccessible or not completed by the participants at the time of the study.

A standardized, fully-inactive placebo tvCVS neuromodulation waveform treatment delivered twice daily by the study device was used for this group at all Study sites.

Number of participants that experienced a reduction of 50% or more in Monthly Migraine Headache Days (total days during a month on which a migraine occurred) during the third month of device use as compared with their pre-device use Baseline Period.

Only participants who were confirmed to meet eligibility criteria & received either placebo (completely inactive) or fully active devices and completed primary and secondary outcome effectiveness measures were included in the overall number of participants analyzed for this outcome.

For both Active and Placebo, all participants with baseline and third month of data were included in analysis. Additional missing data comes from participants not being fully compliant with headache diary.

After three months of Device use, the average Total Monthly Headache Pain Score compared to the average derived from the Pre-use Baseline Period (1 month). This is calculated by adding the cumulative maximum pain scores for all days the subject had a headache, as noted as the maximum daily headache pain score on a scale of 1 (lowest pain)-10 (highest pain) for each headache day as reported by the subject in their daily headache diary. Each month was counted as 28 days. Therefore, the total possible score for each month was 28-280. A negative number indicates a reduction in pain score.

Only participants who were confirmed to meet eligibility criteria, received either active or placebo (completely inactive) treatments, and completed this effectiveness measure were included in the overall number of participants analyzed for this outcome.

Additional missing data comes from participants not being fully compliant with headache diary.

A patient's Pre-device use Baseline Period mood score from the Beck Depression Index is compared with those at the end of the 3 month Device use period. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, with each of the 21 items, rated on a 4-point scale (0-3). The total scores rage from 0-63. The higher the score the more depressed. Mood scores are assessed for: decline, no change, or an improvement. A negative score indicates improvement in mood.

Only participants who were confirmed to meet eligibility criteria and completed baseline and month 3 for this measure were included in the overall number of participants analyzed for this outcome. As this is a safety measure, all (active, placebo, and partially active) participants were followed and outcomes presented.

The purpose of this study endpoint is to verify, using the Berg Balance test, the absence of change in material dizziness (with the associated risk of falls) as a consequence of using the Device. The test consists of 14 balance- related tasks ranging from standing up from a sitting position to standing on one foot. Each task is graded from 0 - 4, and the final measure is the sum from all elements of the Test: • 41-56 = low risk of fall • 21-40 = medium risk of fall • 0-20 = high risk of fall. Possible scores range from 0-56. Scores of zero indicate no change in balance.

Only participants who were confirmed to meet eligibility criteria and completed this measure were included in the overall number of participants analyzed for this outcome. As this is a safety measure, active, placebo, and partially active groups were included.

A patient's Pre-use Baseline Period cognitive speed scores, using the Digit Symbol Coding assessment, will be compared with those at the end of the Device use period. The Digit-Symbol Subtest of the WAIS-III, is a timed pencil-and-paper task that measures processing speed and visual-motor coordination. It involves matching symbols to numbers using a key, with the goal of completing as many correct matches as possible within a 120-second time limit. The number of correct matches completed is counted. The lowest possible count is 0 (zero correct matches). The higher the number of correct matches completed, the better the cognitive speed of the participant. Cognitive speed will be assessed for: a decline, no change, or an improvement. A positive number indicates improvement.

Only participants who were confirmed to meet eligibility criteria and completed this safety measure were included in the overall number of participants analyzed for this outcome. As this was a safety measure, active, placebo and partially active groups were followed and results presented.

A patient's Pre-use Baseline Period memory scores, using Short Term memory test (an old/new paradigm for face recognition) are compared with those at the end of the 3-month Device use period. This assessment was created by the study Neuropsychologist where participants were shown faces at baseline then shown another set which included a subset then had seen before and had to say if they had seen them before later during the visit (to test short term memory). Scores range from 0-10. Higher scores indicate better short term memory. Memory scores were assessed for: a decline, no change, or an improvement from baseline to the end of treatment month 3. A negative score indicates improvement.

Only participants who were confirmed to meet eligibility criteria and completed this outcome measure were included in the overall number of participants analyzed for this outcome. As this was a safety measure, all (active, placebo, and partially active) participants with baseline and third month of data were included in analysis.

This measures counts the number of times abortive medications are taken. The baseline count is subtracted from the third month count. A negative number indicates a reduction in abortive medications used. The greater the negative number, the more reduced the use of abortive medications.

Only participants who were confirmed to meet eligibility criteria and had baseline and month 3 data for this outcome were included in the overall number of participants analyzed for this outcome. As this is an effectiveness measure, only Active and Placebo (fully inactive) participants were followed and included in analysis. Additional missing data comes from participants not being fully compliant with headache diary.

A standardized, fully-inactive placebo tvCVS neuromodulation waveform treatment delivered twice daily by the study device was used for this group at all Study sites.

The description of this treatment is a standardized partially-active neuromodulation waveform delivered twice daily was used for the first 20 participants randomized to the placebo group at all Study sites.

While the participants in this group were supposed to have received a fully-inactive waveform, their devices were found to be delivering an unintended partially-active treatment. This was discovered well after the study had begun. As their results did not represent use of a true (i.e., fully inactive) device, these participants were separated from the main placebo group and followed for only safety (adverse events and safety outcome measures) for the duration of the study.