Cefaly Technology has announced the results of a clinical study demonstrating that two-hour treatment with its external trigeminal nerve stimulation (e-TNS) Cefaly device is a safe and effective alternative to pharmaceuticals for the acute treatment of migraine attacks in the out-of-hospital setting.
“The Cefaly device provides patients with a non-medication option for the prevention and acute treatment of migraine,” said study author Deena Kuruvilla (Westport Headache Institute, Westport, USA). “It is especially helpful to add to a medication regimen or use for people who have had a negative experience with migraine medications.”
The TEAM (Trial of e-TNS for the acute treatment of migraine) study was the first prospective, double-blind, randomised, sham-controlled clinical trial of two-hour e-TNS treatment for acute migraine attack in an at-home scenario, according to a company press release. Cefaly also claims this is the largest sham-controlled clinical trial examining the use of any e-TNS therapy for the treatment of migraine headache.
The release notes that there are several limitations to conventional anti-migraine medications, and many patients prefer to avoid medications to treat their migraine headaches, resulting in up to 40% of migraine patients having an unmet need in this space.
E-TNS is a medical device treatment that offers a non-pharmacological, non-invasive approach for patients with migraine who prefer to avoid or have intolerances to medications, or require complementary therapy in their migraine management. Worn on the forehead, the Cefaly e-TNS device delivers a mild electric stimulation to reduce pain signals of the trigeminal nerve—a primary pathway for migraine pain.
The TEAM study spanned nine months and was conducted at 10 centres across the USA. It enrolled 538 patients aged 18–65 years with episodic migraine, with or without aura, who had moderate- to severe-intensity migraine attacks two-to-eight times per month. Subjects who met all of the study criteria were randomly assigned to either the verum or sham group, and were provided with a headache diary and educated on how to use the Cefaly device, the release further details.
During a two-month period, patients were instructed to self-administer the e-TNS treatment, according to the training and instruction they received, within four hours of migraine onset or within four hours of awakening with migraine headache. Neurostimulation was applied with the Cefaly e-TNS device for a two-hour, continuous session.
In the verum group, results as compared to the sham group were as follows:
- Pain freedom at two hours was 7.2% higher (25.5% compared to 18.3%; p=0.043)
- Resolution of the most bothersome migraine-associated symptom was 14.1% higher (56.4% compared to 42.3%; p=0.001)
- Pain relief at two hours was 14.3% higher (69.5% compared to 55.2%; p=0.001)
- Absence of all migraine-associated symptoms at two hours was 8.4% higher (42.5% compared to 34.1%; p=0.044)
- Sustained pain freedom and pain relief at 24 hours was 7% and 11.5% higher in verum (22.8% and 45.9%) than sham (15.8 and 34.4%; p=0.039)
- No serious adverse events were reported.
Study authors concluded that the use of self-administered, two-hour e-TNS therapy is a safe and effective therapeutic option, with or without the use of acute anti-migraine medications. Their findings have been published in the journal Scientific Reports.
“So many people who live with migraine pain are desperate for a solution that they can use safely at home,” said Cefaly CEO Jen Trainor McDermott. “As the TEAM study shows us, Cefaly provides the powerful, sustained pain relief they need.”