Temporal Analysis of Remote Electric Neuromodulation for The Prevention of Migraine

Blumenfeld et al., Pain Management, 2023

Aim: To evaluate the onset, magnitude and persistence of efficacy of remote electrical neuromodulation (REN) compared with placebo for the preventive treatment of migraine.

Materials & methods: Analysis was conducted on data from a prospective, double-blind, placebo-controlled clinical trial, which assessed the efficacy of REN for the prevention of migraine. The number of monthly migraine days (MMD) per group was calculated in 2-week intervals and compared between the groups.

Results: Differences between the active (N = 95) and placebo (N = 84) groups reached significance at 2 weeks: therapeutic gain 0.84 MMD; p = 0.036. 4 weeks gain 1.59 MMD; p = 0.025, 6 weeks gain 2.27 MMD; p < 0.001, 8 weeks gain 2.68 MMD; p < 0.001.

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 †
Conclusion: REN treatment applied every other day for the prevention of migraine was found superior to placebo as early as 2 weeks after the beginning of the intervention in both the whole group analysis and the episodic migraine sub-group. In the chronic migraine sub-sample statistical significance was achieved after 6 weeks of treatment. The difference between the active and placebo groups grew in magnitude at each bi-weekly measured time point, reaching a peak at 8 weeks. Collectively, the results indicate that REN provides effective early and sustained reduction in monthly migraine days.