Table 1:
Characteristics of Studies Included in the Clinical Literature Review, Cluster Headache
| Author, year (study) | Country, sites, n | Sample size, n | Population | nVNS indication and protocol | Intervention | Comparator | Length of follow-upa |
|---|---|---|---|---|---|---|---|
| Gaul et al, 20 1 653 (PREVA) Gaul et al, 201754 (PREVA post hoc) |
Europe (4 countries), 10 | 97 | Adults (18-70 y) Chronic cluster headache (ICHD 3B) |
Prevention: 3 doses, 5 min apart, 2 times/d, right side of neck Acute treatment: optional, 3 doses at pain onsetb |
nVNS and standard of care | Standard of care | 4 wk |
| Silberstein et al, 201651 (ACT1) | United States, 20 | 150 | Adults (18-75 y) Episodic or chronic cluster headache (ICHD 2) |
Acute treatment: 3 doses to right side of neck; only 1 attack treated per 12 h | nVNS and standard of care | Sham and standard of care | 1 mo or until 5 cluster headache attacks were treated |
| Goadsby et al, 201852 (ACT2) | Europe (4 countries), 9 | 102 | Adults (≥ 18 y) Episodic or chronic cluster headache (ICHD 2) |
Acute treatment: 3 doses ipsilateral to attack; if not aborted in 9 min, 3 additional doses. Minium 6 h between sessions | nVNS and standard of care | Sham and standard of care | 2 wk |
Abbreviations: ICHD, International Classification of Headache Disorders; nVNS, noninvasive vagus nerve stimulation.
a
Only follow-up during the randomization period was included.
b
Participants were advised not to administer preventive treatment within 2 h after acute treatment.