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
	Acute CH treatment	Goadsby et al 23	Yes	Yes^¶	NA	High
	CH prevention‡	Gaul et al 24	Yes	Yes	NA	High
	CH prevention‡	Marin et al 25	Yes	Yes	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.