Abstract: Migraines and headaches are difficult to treat debilitating neurological conditions that leave physicians and their patients with few options for sustained relief from severe chronic pain. All available therapies have considerable side-effects or limitations, leading many patients to resort to drug cocktails including narcotics. To reduce or eliminate the need to use opiates and systemic pharmaceuticals to treat headaches and migraine, Thermaquil developed the first noninvasive, drug-free, patient-controlled reversible nerve block device for long term pain management based on novel mechanisms-of-action that we discovered. Thermaquil has met with more than 300 physicians and headache patients who have vetted and guided the development of Thermaquil’s noninvasive nerve block device. The system is designed to easily be used during normal daily activities. We’ve demonstrated clear efficacy of thermal neuromodulation in single-arm studies with highly complex patients who have tried and failed all other available treatments. Our 45 participants’ baseline pain of 6.1 ± 1.7 was significantly reduced to 2.6 ± 2.5 ( p < 0.05, p = 6e-12). Most participants have had constant headache every day over the past 28 days, which would exclude them from most other headache and migraine clinical trials. The proposed study begins with a 28-day lead-in phase to establish a baseline for participant headache frequency, intensity, medications used, other healthcare utilization, and quality of life. After the baseline period, all participants are randomized into active or control arms and given a single treatment. The study continues for 12 weeks with active versus control therapy arms before all participants are given active therapy for an additional 12 weeks. This sham-controlled study will provide evidence of the safety and effectiveness of the Thermaquil device relieving migraine and headache attacks. Successful completion of the project will 1) justify the company to pursue a larger efficacy/pivotal trial to move towards regulatory approval and 2) result in additional investment opportunities for Thermaquil to expedite our clinical program to rapidly bring this product to market to help stop migraine and other pain for individuals with chronic migraine or other headaches.

Project Narrative Chronic migraines and other headaches and are debilitating neurological conditions that affect millions of Americans, resulting in hundreds of thousands of ER visits annually where many patients are prescribed opioids. Thermaquil has discovered a new way of stopping migraine and other headache pain by noninvasively blocking cranial pain signal transmission that has led to the discontinuation of narcotics and other addictive pain medications. This project will test the Thermaquil system in a randomized controlled trial to demonstrate safety and effectiveness for stopping headache and migraine attacks and preventing migraines and other headaches.