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Table 1 Summary of Clinical Utility Outcomes at 120 Minutes After Treatment Initiation (Double-blind and Open-label Periods)

From: Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial

End Point

Pain Intensity at Treatment Initiation

Double-blind Period

Open-label Period

nVNS

Sham

nVNS

First Attack

 % ≥1-point pain improvement

–

46.8**

26.2

42.9

 % without rescue medication

–

59.3*

41.9

49.1

 % pain-free response

Mild

50.0*

25.0

56.9

Moderate

20.4

22.2

14.8

Severe

19.2

16.7

23.3

All Attacks

 % ≥1-point pain improvement

–

39.4**

26.4

41.8

 % without rescue medication

–

52.3**

37.3

49.7

 % pain-free response

Mild

46.7*

30.1

48.6

Moderate

17.1

16.1

13.8

Severe

12.2

10.3

14.6

  1. *P < 0.05 vs sham in the double-blind period
  2. **P < 0.01 vs sham in the double-blind period
  3. Abbreviation: nVNS non-invasive vagus nerve stimulation