DARIEN, Conn., Aug. 9, 2023 /PRNewswire/ -- Medical device maker CEFALY Technology will present findings from the TEAM (a phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine) study at the Military Health System Research Symposium (MHSRS) August 14-17, 2023, in Kissimmee, FL.
MHSRS is the Department of Defense's foremost scientific meeting and the premier venue for presenting new scientific knowledge resulting from military-unique research and development. The MHSRS provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related healthcare initiatives.
Migraine is a common, though often misunderstood, and debilitating neurological disorder. U.S. service members are affected by migraine at a rate 3 times higher than U.S. civilians. Furthermore, antimigraine medications may be ineffective, associated with performance-impairing adverse effects, or impractical to employ based on a service member's military occupational specialty (MOS), frequency of deployments, or unique operational demands.
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 TEAM study was the largest prospective, multicenter, randomized, double-blind, sham-controlled clinical trial to examine the efficacy and safety of 2-hour continuous e-TNS treatment of a single moderate or severe migraine attack at home among U.S. civilians.
TEAM study authors Deena E. Kuruvilla, MD, Joseph I. Mann, MD, Stewart J. Tepper, MD, Amaal J. Starling, MD, Gregory Panza, PhD, and Michael A. L. Johnson, MD, concluded that treatment with 2-hour e-TNS was a safe and effective, non-invasive, and non-pharmacological option for the acute treatment of migraine attacks.
The TEAM study found that use of e-TNS therapy for acute migraine treatment provided substantially higher rates of migraine resolution at 2 and 24 hours post-treatment, resolution of migraine-associated most bothersome symptoms, resolution of all migraine-associated symptoms, and pain relief at 2 and 24 hours. No serious adverse events were reported.
"The CEFALY device has a favorable safety and tolerability profile, is practical and simple to use, and has been proven effective in treating acute migraine attacks, making it a tool well adapted to meet the needs of the U.S. service member suffering from migraine," Dr. Johnson said. "My colleagues and I look forward to presenting these findings at MHSRS and to continuing our research regarding the effectiveness of e-TNS in treating multifaceted migraine symptoms."
"CEFALY Technology is proud to partner with VA Health Care to provide clinically proven, drug-free migraine treatment to veterans," said Jen Trainor McDermott, CEO of CEFALY Technology. "We're thrilled to join the esteemed scientific community at MHSRS as part of our efforts to improve the lives of veterans and military service members 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.
Jen Trainor McDermott
SOURCE CEFALY Technology