PDF: PREMICE
(2013)Objective
Cefaly - To evaluate the efficacy and safety of supraorbital transcutaneous neurostimulation (STNS) using the Cefaly® device in the prevention of migraine.
Study Summary
• 50% responder rate significantly higher with active treatment vs. sham.
• No adverse events reported.
Intervention
Multicentre, randomized, double-blind, sham-controlled trial across five Belgian headache clinics. Patients with ≥2 migraine attacks/month were randomized to daily 20-minute sessions of verum or sham stimulation for 3 months after a 1-month run-in period.
Inclusion Criteria
Patients with ≥2 migraine attacks per month.
Study Design
Arms: STNS with Cefaly® vs. sham stimulation
Patients per Arm: 67 total; specific distribution not detailed
Outcome
• 50% responder rate: 38.1% in verum vs. 12.1% in sham (p=0.023).
• Significant reductions in migraine attacks (p=0.044), headache days (p=0.041), and acute medication use (p=0.007) in verum group only.
• No adverse events in either group.
Bottom Line
STNS with the Cefaly device is effective as preventive therapy for migraine, with a therapeutic gain of 26% that is comparable to other preventive anti-migraine treatments, and has an excellent safety profile with no adverse events
Major Points
- This was a multi-centre, double-blind, randomized, sham-controlled trial conducted at 5 Belgian tertiary headache clinics
- 67 patients with ≥2 migraine attacks per month were randomized after a 1-month run-in period to 3 months of daily treatment
- Mean monthly migraine days decreased significantly in the verum group (from 6.94 to 4.88, p=0.023) but not in the sham group (6.54 to 6.22, p=0.608)
- The 50% responder rate was significantly higher with verum STNS (38.1%) compared to sham (12.1%), p=0.023
- The therapeutic gain of 26% is within the range of other preventive drug and non-drug anti-migraine treatments
- Secondary endpoints also favored verum: monthly migraine attacks (p=0.044), monthly headache days (p=0.041), and monthly acute anti-migraine drug intake (p=0.007)
- The safety profile was excellent with no adverse events reported in either group
- Both patients and enrolling neurologists were blinded to treatment allocation
- STNS offers a non-pharmacological alternative for migraine prevention without the side effects of preventive medications
- Previous pilot studies had shown encouraging results for STNS in migraine prevention
Study Design
- Study Type
- Multi-centre, double-blind, randomized, sham-controlled, parallel-group trial presented as poster at The European Headache and Migraine Trust International Congress
- Randomization
- Yes
- Blinding
- Double-blind: patients and enrolling neurologists were blinded to randomization (verum vs sham)
- Sample Size
- 67
- Follow-up
- 3 months treatment period following 1-month run-in
- Centers
- 5
- Countries
- Belgium
Primary Outcome
Definition: Change in monthly migraine days from run-in (baseline) to month 3 of treatment
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 6.22 (from 6.54 baseline) | 4.88 (from 6.94 baseline) | - | Verum: p=0.023; Sham: p=0.608 |
Limitations & Criticisms
- This is a poster presentation with limited methodological detail; full publication would provide more comprehensive information
- Specific per-arm sample sizes not provided (only total n=67)
- Baseline characteristics beyond mean migraine days not reported
- Exclusion criteria not specified
- Statistical methods not detailed
- Short follow-up duration (3 months) - longer-term efficacy and durability of effect unknown
- Conducted only in Belgium at tertiary headache clinics, limiting generalizability
- No information on patient demographics, comorbidities, or previous treatment failures
- Mechanism of action of STNS for migraine prevention not fully elucidated
- Cost-effectiveness analysis not performed
- Optimal treatment duration and frequency not established
- Patient selection criteria beyond attack frequency not specified
Citation
Schoenen et al. The Journal of Headache and Pain 2013, 14(Suppl 1):P184