|Project #||Project Title||Research Focus Area||Research Program||Administering IC(s)||Institution(s)||Investigator(s)||Location(s)||Year Awarded|
|Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches||Cross-Cutting Research||Small Business Programs||NINDS||THERMAQUIL, INC.||POPIELARSKI, STEVE||Philadelphia, PA||2021|
FOA Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
FOA Number: RFA-NS-20-010
Migraines and other headaches are often debilitating for patients, yet few treatment options providing sustained relief exist. All available therapies, including frequently prescribed opioids, have considerable side effects or limitations. Therefore, novel treatment approaches are needed to reduce or eliminate the need to use opiates and other systemic pharmaceuticals. Thermaquil Inc. has developed a new way of stopping migraine and other headache pain by noninvasively blocking pain signal transmission in the head, which in initial studies allowed patients to discontinue use of opioids and other addictive pain medications. Thermaquil will now be conducting a larger randomized controlled trial to demonstrate the safety and effectiveness of this novel approach. After a baseline period, patients will be randomly assigned to the active or control condition and receive a single treatment. The study will continue for 12 weeks with the active versus control arms, before all patients will be given active therapy for an additional 12 weeks.