REN for Migraine
Year of Publication: 2023
Link: https://doi.org/10.1111/head.14469
PDF: https://headachejournal.onlinelibrary.wi...1111/head.14469
PDF: Clinical Question
In adolescents with migraine, does frequent use of a wearable remote electrical neuromodulation (REN) device for acute treatment also reduce monthly migraine treatment days (i.e., provide a preventive benefit)?
Study Overview
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
- REN use reduced monthly migraine treatment days (MMTD) over 3 months in adolescents.
- 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.
Patients per Arm
83
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.
Design
Arms
| Field | REN wearable (Nerivio) |
|---|---|
| Intervention | Remote electrical neuromodulation (Nerivio) on the upper arm, used for acute migraine treatment; ≥10 treatments in month 1, ≥3 per month in months 2–3; each session 45 min. |
| Duration | 3 months |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Change from baseline in monthly migraine treatment days (surrogate for preventive benefit). | Primary | ||||
| Device-related adverse events | Adverse | 1/83 (1.2%) | |||
| Arm pain (device-related, minor, resolved) | Adverse | 1/83 (1.2%) | |||
| Serious adverse events | Adverse | 0/83 (0%) | |||
| Systemic adverse events | Adverse | 0/83 (0%) | |||
Based on: REN for Migraine (2023)
Reviewed by: Monique Montenegro, MD
Content summarized and formatted by NeuroTrials.ai.