External Trigeminal Nerve Stimulation Device Shows Efficacy for Acute Treatment of Episodic Migraine

A clinical study (NCT03465904) showed that 2-hour treatment with an external trigeminal nerve stimulation device (Cefaly Dual Enhanced; Cefaly, Darien, CT) is a safe and effective nonpharmaceutical alternative for acute treatment of migraine attacks in an out-of-hospital setting.

In participants who received actual vs sham treatment: 

• Pain freedom at 2 hours occurred in 25.5% vs 18.3% (P=.043), 
• Resolution of the most bothersome migraine-associated symptom occurred in 56.4% vs 42.3% (P=.001),
• Pain relief at 2 hours occurred in 69.5% vs 55.2% (P=.001),
• Absence of all migraine-associated symptoms at 2 hours occurred in 42.5% vs 34.1% (P=.044), 
• Sustained pain freedom and pain relief at 24 hours was 22.8% and 45.9% vs 15.8% and 34.4% (P=.039) 

"The Cefaly device provides patients with a non-medication option for the prevention and acute treatment of migraine,” said Deena Kuruvilla, MD, neurologist and medical director, Westport Headache Institute. “It is especially helpful to add to a medication regimen or use for people who have had a negative experience with migraine medications." 

The Cefaly e-TNS device is worn on the forehead and delivers mild electric stimulation to reduce pain signals of the trigeminal nerve, a primary pathway for migraine pain. 

The study included 538 patients, age 18 to 65 years with episodic migraine with or without aura; participants were randomly assigned to receive actual vs sham treatment and reported their migraine attacks and related symptoms with a headache diary. No serious adverse events were reported.