Cefaly
Summary:
Cefaly is an external trigeminal nerve stimulator (e-TNS) worn on the forehead. It delivers electrical pulses to the supraorbital nerve and is used for both acute and preventive migraine treatment.
Biological Plausibility
Cefaly stimulates the supraorbital branch of the trigeminal nerve, a major pathway in migraine pathophysiology. Neuroimaging studies show it modulates pain-related areas in the thalamus and brainstem. This aligns with known mechanisms of migraine, especially the role of trigeminovascular pathways in headache generation.
Evidence
Multiple randomized, sham-controlled trials—including the PREMICE study—demonstrate a statistically significant reduction in migraine days compared to sham. A real-world observational study of over 2,000 users reported safety and satisfaction consistent with clinical trials.
Effect Size
Users experience an average reduction of 2 migraine days per month. About 38% of patients achieve at least a 50% reduction in migraine frequency, particularly with daily preventive use.
⚠️ Risk
Side effects are typically minor, including tingling or skin discomfort at the electrode site. Serious adverse effects are rare, and long-term use has been well-tolerated in studies.
Cost
$$$
Scores
- Benefit: 4
- Burden: 5
- Ratio: 0.8
Clinical Takeaways
- Effective non-drug option for prevention and acute migraine relief.
- Best results seen with daily use for at least 3 months.
- Well-suited for patients who prefer non-pharmacologic treatment or have medication intolerance.
Key References
- Schoenen J, et al. *Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial.* Neurology. 2013.
- Magis D, et al. *Safety and patients’ satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with Cefaly in headache treatment: a survey of 2,313 users.* J Headache Pain. 2013.