ShiraTronics Begins Key Study of Implantable Neuromodulation for Chronic Migraine

ShiraTronics, a pioneer in neuromodulation technology, has announced the launch of its FDA-approved Investigation Device Exemption (IDE) pivotal trial known as the RELIEV-CM2 Clinical Study. This landmark trial has seen the first implants of ShiraTronics’ neuromodulation therapy for chronic migraine in both the United States and Australia. This step marks a significant advancement in the development of solutions aimed at aiding individuals affected by chronic migraines, a condition that severely impacts daily life.

The RELIEV-CM2 Clinical Study intends to enroll up to 148 patients across the United States and Australia. The purpose of this study is to evaluate the long-term safety and efficacy of ShiraTronics’ implantable neuromodulation therapy. Unlike traditional treatments that focus on managing symptoms, the ShiraTronics System seeks to provide preventative and sustained relief for those who suffer from chronic migraines, which can result in more than 15 headache days per month and are often resistant to current treatments.

Dr. Sandeep Vaid performed the first implantation of the ShiraTronics System in the United States. He highlighted the significance of this new therapy in migraine management, noting the profound impact chronic migraine has on individuals' lives by limiting daily activities and affecting overall well-being. Dr. Vaid, who is board-certified in Pain Management, Neurology, and Brain Injury Medicine, sees this device as a promising advance that could improve patients' daily functioning and quality of life, especially for those who have not found success with other treatment options.

Chronic migraine affects approximately 2% of the global population and can lead to severe, pulsating headaches, sensory sensitivity, nausea, and fatigue. Those with chronic migraine experience headaches at least 15 days per month, with at least eight days featuring intense migraine symptoms. Despite the availability of various treatments like prescription pills, CGRP inhibitors, and Botox injections, many patients in the United States continue to struggle with the disease, as current preventive treatments often fall short, leading to a significant impact on their quality of life and productivity.

ShiraTronics designed its system to address these unmet needs. The device delivers targeted electrical impulses to key nerve pathways, aiming to relieve, interrupt, and prevent the frequency and severity of migraines. This approach provides a non-pharmacologic option to those seeking a solution to the debilitating effects of chronic migraines.

Current migraine treatments primarily focus on symptom management and may lead to dependency, rebound headaches, or difficult side effects. Preventive options often require regular injections, which can disrupt patients' lives. The ShiraTronics System aims to mitigate these issues by using precise, around-the-clock electrical neuromodulation to reduce migraine frequency and intensity, potentially allowing patients to maintain their daily activities with less reliance on continuous medication or invasive treatments.

Initial results from the RELIEV-CM Pilot Study have been encouraging. Among a group of 10 chronic migraine patients who had not responded to conventional treatments, 80% reported a 50% reduction in migraine frequency after three months, with some also experiencing reduced severity. Additionally, 60% of participants reported decreased use of acute medications, with several discontinuing them within six months.

Associate Professor Marc Russo, an expert in neuromodulation and former President of the International Neuromodulation Society, has expressed optimism about the procedure. He emphasized the minimally invasive nature of the implantation process and its promising initial results.

As the RELIEV-CM2 Clinical Study continues, ShiraTronics is working closely with healthcare professionals and patients to evaluate the long-term potential and safety of its neuromodulation therapy. The company is dedicated to advancing this technology with the aim of improving patient outcomes and making this innovative approach accessible to chronic migraine patients in the future. The study represents a significant step toward offering a new therapy option for those who have not found relief through traditional treatments.