PDF: REN for Migraine
(2023)Objective
To assess whether frequent use of a wearable REN device for acute migraine treatment in adolescents leads to preventive benefits, reflected by reduction in monthly migraine treatment days.
Study Summary
• Suggested preventive benefits with consistent 2-hour acute treatment efficacy.
• Device was well tolerated with minimal adverse effects.
Intervention
Prospective real-world study (NCT05769322) of adolescents aged 12–17 using the Nerivio® REN device at least 10 times in month 1 and ≥3 times in each of months 2 and 3. Each session lasted 45 minutes. Effectiveness was assessed by changes in MMTD and 2-hour post-treatment responses. No placebo arm was used.
Inclusion Criteria
Adolescents aged 12–17 using REN ≥10 days in a 28-day month, and ≥3 days in each of the next two months. Total of 83 participants (mean age 15.9 years; 89% female).
Study Design
Arms: Single-arm: All received REN wearable treatment
Patients per Arm: 83
Outcome
• Pain relief in ≥50% of treatments: 61.9%; pain freedom: 24.5%.
• Functional improvement: 67.4%; complete functional disability relief: 41.3%.
• Disappearance of associated symptoms: photophobia 39.5%, phonophobia 50%, nausea/vomiting 65.9%, ≥1 symptom 65.9%.
• Safety: 1 minor arm pain event, no serious adverse events.
Bottom Line
Remote electrical neuromodulation (REN) via the upper arm significantly improved acute migraine pain: pain freedom at 2h 37.4% vs 18.4% placebo (P=0.003). Non-invasive, wearable device (Nerivio). Published Headache 2019. 252 patients, sham-controlled.
Major Points
- Pain freedom at 2h: 37.4% (REN) vs 18.4% (sham); P=0.003.
- Pain relief at 2h: 66.7% vs 38.8% (P<0.001).
- 252 patients with episodic migraine. Double-blind, sham-controlled.
- Nerivio device: wireless, upper arm, conditioned pain modulation via electrical stimulation.
- MBS-free at 2h (freedom from most bothersome symptom): 46.3% vs 22.2% (P<0.001).
- Sustained pain freedom at 24h: 31.5% vs 14.9% (P=0.003).
- AEs mild: arm discomfort/paresthesia. No serious AEs.
- FDA-cleared (2019). Non-pharmacological acute migraine treatment option.
- Mechanism: conditioned pain modulation — peripheral noxious stimulus inhibits central pain processing.
- Published Headache 2019 (Yarnitsky et al.). Theranica sponsored.
Study Design
Primary Outcome
Definition: Change from baseline in monthly migraine treatment days (surrogate for preventive benefit).
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | - | - | - |