Temporal Analysis of Remote Electric Neuromodulation for The Prevention of Migraine

Figures & data

Table 1. Demographic and clinical characteristics of the modified intend to treat dataset.

Parameter		All (n = 179)	Active (n = 95)	Sham (n = 84)	p-value^†
Age (years)	Average (SD)	42.9 (13.1)	42.5 (12.3)	43.3 (14.0)	0.685
Gender	Female, n (%)	151 (84.4%)	80 (84.2%)	71 (84.5%)	0.954
	Male, n (%)	28 (15.6%)	15 (15.8%)	13 (15.58%)
Race (n)	Caucasian, n (%)	167 (93.3%)	88 (92.6%)	79 (92.6%)	0.705
	Asian, n (%)	2 (1.1%)	0 (0.0%)	2 (2.4%)
	Black/African–American, n (%)	8 (4.5%)	5 (5.3%)	3 (3.6%)
	Other, n (%)	2 (1.1%)	2 (1.1%)	02 (0.0%)
Chronic migraine^‡	n (%)	124 (69.3%)	62 (65.2%)	62 (73.85%)	0.323
Preventive medications	n (%)	69 (38.5%)	32 (33.7%)	37 (44.0%)	0.136
Aura^§	n (%)	43 (24.0%)	26 (27.4%)	17 (20.2%)	0.265

† t-test for continuous variables, chi-square test for nominal variables.

‡ Diagnosed prior to enrollment.

§ Aura preceding a migraine attack.

Figure 1. Monthly migraine days per group.

Table 2. Mean change from baseline in the number of migraine days per month.

Week	Active group (n = 95)		Placebo group (n = 84)		Group comparison
	Mean migraine days per month	Mean change from baseline	Mean migraine days per month	Mean change from baseline	Therapeutic gain	Significance (p-value)
0	11.76	–	11.98	–	–	–
2	10.09	-1.67	11.15	-0.83	0.84	0.036 ^†
4	8.69	-3.07	10.50	-1.48	1.59	0.025 ^†
6	8.18	-3.58	10.67	-1.31	2.27	<0.001 ^†
8	7.79	-3.97	10.69	-1.29	2.68	<0.001 ^†

† Indicate statistical significance (p < 0.05).

Table 3. Sub analysis of episodic and chronic sub-samples.

Characteristic	Week	Active group		Placebo group		Group comparison
		Mean migraine days per month	Mean change from baseline	Mean migraine days per month	Mean change from baseline	Therapeutic gain	Significance (p-value)
Episodic n = 45:42	0	9.60	–	9.46	–	–	–
	2	7.87	-1.73	8.77	-0.69	1.04	0.039 ^†
	4	6.69	-2.91	8.49	-0.97	2.13	0.021 ^†
	6	6.66	-2.94	8.59	-0.87	2.07	0.008 ^†
	8	6.37	-3.23	8.50	-0.96	2.27	0.003 ^†
Chronic n = 50:42	0	13.71	–	14.49	–	–	–
	2	12.10	-1.61	13.52	-0.97	0.64	0.303
	4	10.50	-3.21	12.50	-1.99	1.22	0.282
	6	9.54	-4.17	12.75	-1.74	2.4	0.019 ^†
	8	9.07	-4.64	12.87	-1.62	3.02	0.002 ^†

† Indicate statistical significance (p < 0.05).

The bold text indicates the main results shown in the table.

Data sharing statement

Data will be shared upon request from the authors.