Implantable Neuromodulation Device Shows Sustained Benefit in Chronic Migraine at 12 Months
The investigational ShiraTronics Migraine Therapy System delivered an average of 9.6 migraine-free days per month, reduced rescue medication use, and improved QOL.
An investigational implantable neuromodulation system for chronic migraine from ShiraTronics was associated with sustained reductions in headache and migraine frequency along with durable improvements in quality of life, according to 12-month follow-up data from the RELIEV-CM pilot study reported today.1
Study participants experienced an average reduction of 9.6 monthly headache days (MHD) and 9.6 monthly migraine days (MMD) from baseline. The year-long findings build on data reported at 12 weeks that showed participants experienced a mean 11.3-day reduction in MHD, with a majority (80%) reaching a reduction of 50% or more, according to ShiraTronics. In addition to decreased morbidity at the 3-month mark, participants reported meaningful improvements in migraine-specific quality of life (MSQ) scores. Additional benefits sustained over the 12-month period were reduction in the severity of migraine headaches and need for rescue medication as well as positive scores for both patient and clinician global assessment of change. No unanticipated adverse events occurred.1
“These 12-month outcomes reinforce the strength and sustainability of our early findings,” Rob Binney, ShiraTronics CEO, said in a statement. “For patients living with chronic migraine – who often cycle through medications with limited or temporary success – the consistency of benefit seen over an entire year is a meaningful signal. We believe this investigational therapy is positioned to address one of the largest unmet needs in neurology and eagerly await further validation when we reveal the results of our Pivotal Study in 2026.”1
Novel Precision Engineering
The ShiraTronics Migraine Therapy System is the first fully implantable platform designed specifically to treat chronic migraine. It delivers low-level, patient-controlled electrical stimulation to the occipital and supraorbital nerves, with the intent of modulating pain signals within the trigeminocervical complex. Patients can use the system continuously or tailor the stimulation to their needs, avoiding the systemic side effects of preventive medications.1
“The long-term results from this pilot study are particularly encouraging and reinforce the potential of this therapy to deliver meaningful, sustained relief for people living with chronic migraine,” Samer Narouze, MD, PhD, and Brian Grosberg, MD, said in the ShiraTronics statement. The physicians, who are national coprincipal investigators on the ongoing RELIVE-CM2 study, said they are "optimistic about what this investigational neuromodulation system could represent for patients who have exhausted conventional treatment options. These findings offer real hope for a population that has long needed better solutions.”1
RELIEVE-CM
The pilot study was a prospective, multi-center trial at 4 international sites. Eligibility was based on a 28-day electronic diary screening period followed by a temporary external trial to test stimulator tolerability before implantation. Participants who advanced to the trial received bilateral subcutaneous placement of pulse generators and leads targeting the occipital and supraorbital nerves. Over 12 months, investigators measured MHD, MMD, MSQ, Migraine Disability Assessment (MIDAS) scores, and rescue medication use.1
“Many of my patients with chronic migraine have tried multiple drug therapies, including CGRPs and Botox, and still suffer significantly,” Matthew Green, MD, a principal investigator in RELIEV-CM, said in the statement. “The sustained improvements we're seeing over a full year with this investigational therapy are both clinically meaningful and personally hopeful, for both patients and physicians.”1
Chronic migraine affects more than 5.5 million people in the US annually and is classified by the World Health Organization as one of the most disabling neurological disorders.2 Current treatments such as CGRP inhibitors and botulinum toxin A often show limited durability or tolerability, and up to 40% of patients discontinue preventive therapies within the first year.3
The ShiraTronics system received FDA Breakthrough Device Designation and is now being evaluated in the RELIEV-CM2 pivotal trial, a larger randomized, double-blind study intended to further assess its safety and efficacy.
References
ShiraTronics announces positive 12-month follow-up results from RELIEV-CM pilot study, demonstrating sustained clinical benefit with investigational implantable neuromodulation therapy for chronic migraine. News release. ShiraTronics. September 16, 2025. Accessed September 16, 2025. https://www.prnewswire.com/apac/news-releases/shiratronics-announces-positive-12-month-follow-up-results-from-reliev-cm-pilot-study-demonstrating-sustained-clinical-benefit-with-investigational-implantable-neuromodulation-therapy-for-chronic-migraine-302555432.html
What is chronic migraine? American Migraine Foundation. Updated June 29. 2021. Accessed September 16, 2025. https://americanmigrainefoundation.org/resource-library/what-is-chronic-migraine/
Lampl C, VanDenBrink AM, Deligianni CI, et al. The comparative effectiveness of migraine preventive drugs: a systematic review and network meta-analysis. J Headache Pain. 2023;24(56). doi:org/10.1186/s10194-023-01594-1
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