Remote electrical neuromodulation is safe and effective for acute migraine

Takeaway

• Remote electrical neuromodulation (REN) is an effective treatment for acute migraine with a favourable safety and tolerability profile.
• It may be an effective alternative for acute migraine treatment with comparable or superior efficacy to commercially available neuromodulation devices.

Why this matters

• REN has the potential to improve patient adherence, migraine management, and the health and quality of life of patients with migraine.

Study design

• A randomised, double-blind, sham-controlled, study of 252 patients with migraine who were randomly assigned 1:1 ratio to active (n=126) and sham simulation group (n=126).
• Migraine pain levels recorded at baseline, 2 and 48 hours and most bothersome symptoms (MBS) recorded at baseline and 2 hours post-treatment.
• Primary outcome: proportion of patients achieving pain relief at 2 hours post-treatment.
• Secondary outcome: pain-free, MBS relief, pain and MBS relief, and MBS freedom at 2 hours post-treatment.
• Funding: None disclosed.

Key results

• In modified-to-intention treat analysis (n=202), higher proportion of patients in active vs sham group at 2 hours post-treatment achieved:
  • pain relief (66.7% vs 38.8%; P<.0001)
  • pain-free relief (37.4% vs 18.4%; P=.003)
  • MBS relief (46.3% vs 22.2%; P=.0008)
  • pain and MBS relief (40.0% vs 15.2%; P=.0004)
• No significant difference was seen in MBS freedom between 2 groups (P=.55).
• The 2-hour pain relief (P=.004) and pain-free (P=.014) superiority was sustained 48 hours post-treatment in active group vs sham group.
• In intention-to-treat analysis (n=252), the incidence of device-related adverse events was low (3.6%) and similar between the 2 groups (4.8% vs 2.4%; P=.499).

Limitations

• Low rate of severe baseline pain intensity and high rate of mild pain intensity.