TEAM
(2022)Objective
e-TNS - To evaluate the safety and efficacy of external trigeminal nerve stimulation (e-TNS) for acute migraine treatment in an at-home setting.
Study Summary
• Sustained pain relief and freedom at 24h were also superior.
• No serious adverse events; paresthesia was the most common side effect.
• Provides a non-pharmacologic option for patients with intolerance or contraindications to medication.
Intervention
Phase 3, double-blind, sham-controlled trial involving 538 adults with 2–8 monthly migraine days, randomized 1:1 to verum or sham e-TNS device used for 2 hours during a single qualifying migraine. Primary endpoints were pain freedom and most bothersome symptom (MBS) resolution at 2h. Secondary endpoints included pain relief, sustained relief/freedom at 24h, and adverse events.
Inclusion Criteria
Adults 18–65 years with episodic migraine (2–8 migraine days/month), migraine onset before age 50, and no more than 15 headache days/month. Excluded if unable to distinguish migraine from tension-type headache, used Botox/supraorbital nerve blocks recently, or had significant comorbidities or device contraindications.
Study Design
Arms: e-TNS (verum) vs. Sham
Patients per Arm: Verum: 259, Sham: 279
Outcome
• MBS freedom at 2h: 56.4% vs. 42.3%; p=0.001
• Pain relief at 2h: 69.5% vs. 55.2%; p=0.001
• Absence of all symptoms at 2h: 42.5% vs. 34.1%; p=0.044
• Sustained pain freedom at 24h: 22.8% vs. 15.8%; p=0.039
• Sustained pain relief at 24h: 45.9% vs. 34.4%; p=0.006
• Rescue med use 2–24h: no significant difference
• Adverse events: 8.5% (verum) vs. 2.9% (sham); p=0.004 (mostly mild paresthesia)