CEFALY Technology today announced the results of a clinical study demonstrating that a two-hour treatment with the CEFALY e-TNS device is a safe and effective non-pharmaceutical alternative for the acute treatment of migraine attacks in an out-of-hospital setting. .
The Trial of e-TNS for the Acute treatment of Migraine (TEAM) study was the first prospective, randomized, double-blind, sham-controlled clinical trial of a 2-hour e-TNS treatment for an acute migraine attack in a patient at home. scenario. The TEAM study is also the largest simulation-controlled clinical trial examining the use of any e-TNS therapy for the treatment of migraine.
A common and debilitating neurological disorder, migraine has been classified by the World
World Health Organization as the second leading cause of disability worldwide. There are several limitations to conventional migraine medications. Additionally, many patients prefer to avoid medication to treat their migraines. As a result, up to 40% of migraine patients have an unmet need for this migraine treatment.
External Trigeminal Nerve Stimulation (e-TNS) is a medical device treatment that offers a non-pharmacological and non-invasive approach for migraine patients who prefer to avoid medication, have drug intolerances, or require complementary therapy in their migraine management. Worn on the forehead, the CEFALY e-TNS device delivers mild electrical stimulation to reduce pain signals from the trigeminal nerve, a primary pathway for migraine pain.
The TEAM study lasted nine months and was conducted at 10 centers across the United States. The study recruited 538 patients aged 18 to 65 with episodic migraine, with or without aura, who had moderate to severe migraine attacks 2 to 8 times per month. Subjects who met all study criteria were randomly assigned to the verum or sham group and received a headache diary and instructed in the use of the CEFALY device.
Over a period of 2 months, patients were asked to self-administer the e-TNS treatment, according to the training and instructions they received, within 4 hours of migraine onset or within 4 hours after waking up with a migraine. Neurostimulation was applied with the CEFALY e-TNS device for a continuous session of 2 hours.
In the verum group, relative to the fictitious group:
• Freedom from pain at 2 hours was 7.2% higher (25.5% versus 18.3%; p=0.043)
• Resolution of the most bothersome migraine-related symptom was 14.1% higher (56.4% vs. 42.3%; p=0.001)
• Pain relief at 2 hours was 14.3% better (69.5% vs. 55.2%; p=0.001)
• Freedom from all migraine-related symptoms at 2 hours was 8.4% higher (42.5% vs. 34.1%; p=0.044)
• Sustained freedom from pain and pain relief at 24 hours were 7.0% and 11.5% higher in the verum (22.8% and 45.9%) than in the sham treatment (15 .8 and 34.4%; p = 0.039)
No serious adverse events were reported.
The study authors concluded that the use of a 2-hour self-administered e-TNS therapy is a safe and effective treatment option, with or without the use of acute anti-migraine medication.
“The CEFALY device offers patients a drug-free option for the prevention and acute treatment of migraine. It is especially useful to add to a medication regimen or to use for people who have had a negative experience with migraine medications,” said Dr. Deena Kuruvilla, one of the study authors. and medical director and board-certified neurologist of the Westport Headache Institute.
“So many migraine sufferers are desperate for a solution that they can safely use at home,” said Jen Trainor McDermott, CEO of CEFALY Technology. “As the TEAM study shows, CEFALY provides the powerful and long-lasting pain relief they need.”