Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
The device applies transcutaneous electrical nerve stimulation to the bicep
The device applies transcutaneous electrical nerve stimulation to the hand
Mayo Clinic
Scottsdale, Arizona, United States
Mean change in pain score
We will also assess the change in migraine pain before versus after treatment with the 100-mm Visual Analogue Scale (VAS), which is a continuum scale that patients can quantify their pain from none (0 mm) to extreme (100 mm) for both treatment sites. The mean score for each patient cohort will be calculated. We will also perform a sub analysis on women versus men.
Time frame: 4 months
Percent of subjects who are responders
For each subject treatment effectiveness will be assessed by both achieving pain relief (if the pain decreases from a 4-point visual rating scale (VRS) of 'severe' or 'moderate' at pre-treatment to 'mild' or 'none' at 120-min post-treatment) or pain-free ('none') status. The percent of subjects that experience a significant reduction in pain relief score (VRS) will be calculated for the verum and sham treatment sites.
Time frame: 4 months
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