Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

Table 1 Baseline characteristics of the cohort

	Intention-to-treat analysis			Per protocol analysis
	1 Hz (n = 22)	25 Hz (n = 24)	Group comparison	1 Hz (n = 17)	25 Hz (n = 22)	Group comparison
Age	43.8 ± 11.5	39.3 ± 12.4	p = 0.21	44.1 ± 11.4	39.0 ± 12.5	p = 0.21
Females	18	21	p = 0.69	13	19	p = 0.68
Headache days/28 days	19.4 ± 4.0	18.9 ± 5.1	p = 0.47	19.1 ± 3.7	19.2 ± 4.7	p = 0.66
Headache intensity (NRS: 0–10)	5.2 ± 1.5	5.0 ± 1.5	p = 0.73	5.0 ± 1.5	5.0 ± 1.5	p = 0.98
Migraine history (years)	27.1 ± 13.0	20.4 ± 12.1	p = 0.08	27.8 ± 11.5	21.4 ± 12.1	p = 0.11
Days with acute headache medication/28 days	10.3 ± 6.4	8.2 ± 4.9	p = 0.24	11.1 ± 6.6	8.6 ± 4.8	p = 0.17
MIDAS score	76.8 ± 64.8	83.6 ± 56.0	p = 0.55	77.2 ± 70.1	82.1 ± 58.0	p = 0.71
HIT-6 score	64.3 ± 4.7	66.0 ± 4.1	p = 0.25	64.8 ± 5.0	66.0 ± 4.2	p = 0.55
BDI	6.9 ± 5.7	7.9 ± 5.6	p = 0.59	6.9 ± 5.9	7.2 ± 5.0	p = 0.95

Demographic and headache characteristics assessed at the first visit or during the baseline period (4 weeks) are given. Values are mean ± SD or numbers of subjects. Results of Mann–Whitney U test or Fisher’s Exact test are given. Headache intensity (NRS: numerical rating scale 0–10)
MIDAS migraine disability assessment, HIT headache impact test, BDI beck’s depression inventory

ISSN: 1129-2377