Table 5.

Clinical evidence of available devices

Device	Study	Authors	CE marked	FDA cleared	AAN Classification of Evidence	GRADE
nVNS	Acute migraine treatment*	Tassorelli et al 21	Yes	Yes	I	High
	Migraine prevention*†	Silberstein et al (EVENT)31	Yes	No	II	Low
	Acute CH treatment	Silberstein et al (ACT1)22	Yes	Yes¶	NA	High
		Goadsby et al 23			NA	High
	CH prevention‡	Gaul et al 24	Yes	Yes	NA	High
		Marin et al 25			NA	Moderate
e-TNS	Acute migraine treatment	Chou et al 26	Yes	Yes	NA	Moderate
	Migraine prevention*	Schoenen et al 27	Yes	Yes	III	Moderate
	Acute CH treatment§	NA	No	No	NA	NA
	CH prevention§	NA	No	No	NA	NA
sTMS	Acute migraine treatment	Lipton et al 28	Yes	Yes	NA	Moderate
	Migraine prevention	Starling et al 29	Yes	Yes	NA	Low
	Acute CH treatment§	NA	No	No	NA	NA
	CH prevention§	NA	No	No	NA	NA

*AAN Classification of Evidence is published for this study.

†The EVENT study was not a pivotal study.

‡Marin et al’s study published outside of predefined date range; included here based on recent FDA clearance.

§No studies identified.

¶FDA cleared for episodic CH only.

AAN, American Academy of Neurology;ACT, acute CH treatment; CH, cluster headache;FDA, Food and Drug Administration; GRADE, Grading of Recommendations Assessment, Development and Evaluation;NA, not available;e-TNS, external trigeminal nerve stimulation;nVNS, non-invasive vagus nerve stimulation;sTMS, single-pulse transcranial magnetic stimulation.