Is Cephaly effective for migraine treatment?

Is Cephaly Effective for Migraine Treatment?

Cefaly is an effective and safe FDA-approved device for migraine prevention, with evidence showing significant reductions in migraine frequency, though it is not included in current major treatment guidelines and should be considered as an adjunctive option rather than first-line therapy.

Current Guideline Position

The most recent American College of Physicians guideline (2025) does not mention Cefaly or any neuromodulation devices in their treatment algorithm for acute or preventive migraine therapy 1. The guideline framework prioritizes pharmacologic interventions including NSAIDs, triptans, and preventive medications (beta-blockers, antidepressants, anticonvulsants) as the evidence-based standard of care 1.

This absence from major guidelines is notable given that Cefaly received FDA approval, suggesting the device may represent an emerging therapy that has not yet been incorporated into mainstream clinical practice algorithms.

Evidence for Cefaly's Efficacy

Preventive Treatment

The strongest evidence supports Cefaly for migraine prevention rather than acute treatment:

• In a double-blind, randomized, sham-controlled trial of 67 episodic migraine patients, the 50% responder rate after 3 months was significantly higher in the active group (38.2%) versus sham (12.1%) 2
• Attack frequency and total headache days were significantly reduced, though headache severity was not 2
• Acute anti-migraine drug intake was reduced by 36.7% in the active treatment group 2
• A Japanese study of 100 patients showed significant decrease in migraine days (8.16 vs. 6.84 days; p=0.0036) after 12 weeks of treatment 3
• The same study demonstrated reduction in migraine attacks (5.33 vs. 3.94; p=0.0002) and acute medication consumption (8.75 vs. 7.83 days; p=0.0166) 3

Patient Populations

Cefaly appears most effective in patients with higher baseline attack frequency:

• Statistical sub-analysis suggested transcutaneous supraorbital nerve stimulation was more effective in patients with higher attack frequency 2
• An open randomized trial confirmed therapeutic efficacy in low-frequency migraine (≤5 attacks/month) 2
• No published data are available for chronic migraine patients 2

Acute Treatment

Limited evidence exists for acute migraine treatment, though one small study (19 patients) showed promise for acute vestibular migraine attacks with 61.3% mean improvement in vertigo and 77.2% mean improvement in headache 4.

Safety Profile

Cefaly demonstrates an exceptionally favorable safety profile compared to pharmacologic preventive therapies:

• In a large survey of 2,313 users, only 4.3% reported side effects, all minor and fully reversible 2
• Most common adverse effect was intolerance to paresthesia sensation 2
• Most severe adverse event was allergic skin reaction to electrode gel 2
• Japanese study showed only 3.0% dropout rate due to adverse effects with no serious adverse events 3
• Compliance was very high at 90.0% in the Japanese cohort 3

This contrasts sharply with preventive medications like beta-blockers (fatigue, depression, nausea) 1, tricyclic antidepressants (drowsiness, weight gain, anticholinergic symptoms) 1, and anticonvulsants which have more significant side effect profiles.

Clinical Positioning

When to Consider Cefaly

Cefaly should be considered in the following clinical scenarios:

• Patients with contraindications to or intolerance of pharmacologic preventive therapies 2
• Patients seeking non-pharmacologic options due to polypharmacy concerns 2
• Episodic migraine patients with ≥2 attacks per month who prefer device-based therapy 3
• Patients with medication overuse headache where reducing acute medication use is a priority 2

Integration with Standard Care

Cefaly should be positioned as adjunctive rather than replacement therapy:

• First-line acute treatment remains NSAIDs (aspirin 650-1000mg, ibuprofen 400-800mg, naproxen sodium 275-550mg) for mild-to-moderate attacks 5, 6
• Triptans remain first-line for moderate-to-severe attacks 5, 6
• Standard preventive medications (propranolol, timolol, amitriptyline) have stronger guideline support 1
• Cefaly can be added when pharmacologic prevention is inadequate, not tolerated, or contraindicated 2

Critical Limitations and Caveats

Important considerations when recommending Cefaly:

• The device has not been studied in chronic migraine populations, limiting its applicability to this common patient group 2
• Effect size is modest—38.2% responder rate means 61.8% of patients do not achieve 50% reduction in attacks 2
• The mechanism of action (increasing activity in orbitofrontal and anterior cingulate cortices) is preliminary and not fully established 2
• Cost considerations are not addressed in the literature, but device-based therapy may have different cost-benefit profile than generic preventive medications 1
• The absence from major 2025 guidelines suggests insufficient comparative effectiveness data against standard pharmacologic therapies 1

Practical Implementation

For patients who choose to trial Cefaly:

• Treatment duration should be at least 12 weeks to assess efficacy, as this was the timeframe used in clinical trials 2, 3
• Patients should maintain headache diaries to objectively track migraine days, attack frequency, and acute medication use 3
• Continue appropriate acute treatment strategies (NSAIDs, triptans) as Cefaly is preventive, not abortive therapy 5, 6
• Monitor for the rare possibility of skin reactions to electrode gel 2
• Set realistic expectations: approximately 40% of patients achieve meaningful benefit 2

The device should not delay initiation of guideline-recommended pharmacologic preventive therapy in patients meeting criteria for prevention (≥2 attacks per month producing ≥3 days of disability, or contraindication/failure of acute treatments) 1.