Table 15:
Characteristics of Studies Included in the Clinical Literature Review, Migraine
| Author, year (study) | Country, sites | Sample size, na | Population | nVNS indication and protocol | Intervention | Comparator | Length of follow-up |
|---|---|---|---|---|---|---|---|
| Silberstein et al, 20 1 656 (EVENT) | United States, 6 | 59 | Adults 18-65 y Chronic migraine (ICHD-2), < 50 y at onset ≥ 15 d/mo in previous 3 mo |
Prevention: 2 stimulations of 2 min to right side of neck, 5 to 10 min apart, 3 times/d | nVNS | Sham | 8 wk (doubleblind period) |
| Tassorelli et al, 201855 (PRESTO) Grazzi et al, 201863 (post hoc) Martelletti et al, 201864 (post hoc) |
Italy, 10 | 248 | Adults 18-75 y Episodic migraine (ICHD-3B), < 50 y at onset 3-8 migraines/mo, < 15 headache d/mo |
Acute treatment: within 20 min of onset, bilateral 120 s stimulation; repeat if no improvement at 15 min; optional bilateral stimulations at 120 min if not pain-free Treated up to 5 attacks and only 1 attack in 48 h |
nVNS | Sham | 4 wk (doubleblind period) |
| Chaudhry et al, 201959 | Germany, 1 | 30 | Adults ≥ 18 y Refractoryb episodic migraine and chronic migraine |
Acute treatment: 1 bilateral stimulation at onset of attack; additional bilateral application allowed after 15-30 min Prevention: 2 min stimulation, 2 times/d, bilaterally |
nVNS and standard of care | Sham | 2 mo |
| Diener et al, 201957 (PREMIUM) | Europe, 22 | 341 | Adults 18-75 y Episodic migraine (ICHD-3B), < 50 y at onset 5-12 migraines/mo, at least 2 lasting > 4 h |
Prevention: 2 consecutive bilateral stimulations, 3 times/d | nVNS | Sham | Baseline: 4 wk Follow-up: 12 wk (doubleblind period) |
| Najib et al, 202258 (PREMIUM II) | United States, 27 | 231 | Adults 18-75 y Episodic or chronic migraine, ≤ 50 y at onset 8-20 headache d/mo, at least 5 d of migraine |
Prevention: 2 consecutive 2 min stimulations to same side of neck, ipsilateral to side of predominant pain, 3 times/d | nVNS | Sham | Baseline: 4 wk Follow-up: 12 wk (doubleblind period) |
Abbreviations: ICHD, International Classification of Headache Disorders; nVNS, noninvasive vagus nerve stimulation.
a
Number randomized.
b
Refractory defined as having failed at least 4 classes of preventive medications.