A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

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.

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.