DARIEN, Conn., July 19, 2023 /PRNewswire/ — Medical device maker CEFALY Technology announced that two post-hoc analyses of the TEAM (a phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine) study were presented as posters at the American Headache Society’s 65th Annual Scientific Meeting June 15-18 in Austin, Texas.
The TEAM study is the largest sham-controlled clinical trial examining the use of any e-TNS therapy for the treatment of migraine. This study evaluated the efficacy and safety of self-administered, 2-hour (two consecutive 1-hour) e-TNS treatments for migraine-associated symptoms.
Researchers Deena E. Kuruvilla, MD, Gregory Panza, PhD, and Michael A. L. Johnson, MD, presented posters on the following topics:
1. A post-hoc subgroup analysis of migraine-associated most bothersome symptoms from the TEAM study
- This analysis compared two outcomes — pain freedom at two hours and resolution of most bothersome symptom (MBS) at two hours — in participants with different migraine-associated MBS, including photophobia, nausea, phonophobia, and vomiting.
- This subgroup analysis from the TEAM study data displayed minimal heterogeneity in the pre-treatment MBS response to e-TNS therapy.
- Overall, the results suggest that the efficacy of e-TNS was relatively consistent regardless of pre-treatment MBS.
2. A post-hoc subgroup analysis in participants with migraine with aura from the TEAM study
- This analysis compared primary and secondary outcomes of e-TNS treatment in patients with aura vs. without aura for the total sample, and within the verum and sham treatment groups.
- Primary outcomes were pain freedom at 2 hours and resolution of most bothersome migraine associated symptoms (MBS) at 2 hours.
- Secondary outcomes were pain relief at 2 hours (reduction of moderate-severe to mild or no pain), resolution of any migraine-associated symptoms at 2 hours, sustained pain freedom at 24 hours, sustained pain relief at 24 hours, and use of rescue anti-migraine therapy between 2-24 hours.
- Overall, the results suggest that the efficacy of e-TNS was relatively consistent regardless of migraine aura status.
“These post-hoc analyses provide further evidence that e-TNS treatment with CEFALY remains beneficial for patients with different migraine characteristics, including people with different migraine-associated symptoms or migraines with and without aura,” Dr. Johnson stated. “The consistent benefit of e-TNS with CEFALY across a diverse group of migraine patients is an exciting finding which should provide hope and promise to people who suffer from debilitating migraine headaches.”
External trigeminal nerve stimulation (e-TNS) is a neuromodulation therapy that uses tiny, precise electrical impulses to directly target and modulate the activity of the trigeminal nerve, the primary pathway for migraine pain. Research has shown that e-TNS both relieves active migraine attacks (acute therapy) and prevents future migraine attacks (preventative therapy). CEFALY is the only FDA-cleared e-TNS device used for the treatment and prevention of migraine that is available without a prescription.
The American Headache Society’s Annual Scientific Meeting is the premier venue for the dissemination of the latest and most up-to-date research and scientific advances underlying the practice of headache medicine. Migraine is one of the most common and debilitating headache disorders worldwide.
“I thank the American Headache Society for providing this opportunity to present the findings from the TEAM study,” said Jen Trainor McDermott, CEO of CEFALY Technology. “CEFALY will continue to support research on the benefits of neurostimulation for migraine, furthering our goal of educating, empowering, and providing relief to people with migraine.”
About the CEFALY device:
CEFALY Technology is the maker of CEFALY, an FDA-cleared, over-the-counter wearable medical device clinically proven to help reduce migraine frequency and relieve migraine pain. CEFALY is a non-invasive device worn on the forehead that targets the trigeminal nerve to modify pain sensation and perception.
The newest version of CEFALY, the Bluetooth-enabled CEFALY Connected, syncs with the CeCe Migraine Management app and enables users to track CEFALY treatments and log migraine attacks on their mobile device. With these insights, people can better understand their migraine patterns and optimize their treatments.
About CEFALY Technology:
CEFALY Technology is a Belgium-based company with U.S. offices based in Darien, Conn., specializing in electronics for medical applications. CEFALY Technology’s mission is to provide innovative, ever-evolving technology that enables people with migraine to take control of their treatment and live happier, healthier lives.
