Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Study Overview
=================
Brief Summary
-----------------
Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.

Official Title
-----------------
Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Conditions
-----------------
Episodic Migraine

Intervention / Treatment
-----------------
* Device: Sham Treatment Location
* Device: Verum Treatment Location


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-100 years, inclusive Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria 4-14 migraine days per month Ability to provide informed consent Demonstrates no contraindication to the use of electrical nerve stimulation Capable and willing to follow all study-related procedures Exclusion Criteria: Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria Any medical condition that would, in the opinion of the investigator, make the subject ineligible Has received botulinum toxin injections within the past 3 months Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant Use of investigational drug/device therapy within the past 4 weeks Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy) No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>Treatment at the bicep location | Device: Sham Treatment Location<br>* The device applies transcutaneous electrical nerve stimulation to the bicep<br>|
| Active Comparator: Verum<br>Treatment at the hand location | Device: Verum Treatment Location<br>* The device applies transcutaneous electrical nerve stimulation to the hand<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4 months |