← Back

PREMICE

Prevention of migraine by supraorbital transcutaneous neurostimulation using the Cefaly device (PREMICE): a multi-centre, randomized, sham-controlled trial

Share Share Copied! Compare

Year of Publication: 2013

Authors: J Schoenen, B Vandersmissen, S Jeangette, ..., D Magis

Journal: The Journal of Headache and Pain

Citation: Schoenen et al. The Journal of Headache and Pain 2013, 14(Suppl 1):P184

Link: http://www.thejournalofheadacheandpain.c...tent/14/S1/P184

PDF: https://pmc.ncbi.nlm.nih.gov/articles/PM...-14-S1-P184.pdf

Clinical Question

Is supraorbital transcutaneous neurostimulation (STNS) with the Cefaly device effective and safe for preventive treatment of migraine in patients with frequent attacks?

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

      

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: 1

Blinding: Double-blind: patients and enrolling neurologists were blinded to randomization (verum vs sham)

Enrollment Period: Not specified

Follow-up Duration: 3 months treatment period following 1-month run-in

Centers: 5

Countries: Belgium

Sample Size: 67

Analysis: Intention-to-treat analysis was used. Specific statistical methods for comparing outcomes between groups not detailed in this poster abstract

Inclusion Criteria

Patients with frequent migraine attacks defined as ≥2 migraine attacks per month

Exclusion Criteria

Not specified in this poster abstract

Baseline Characteristics

Characteristic	Control	Active
Mean monthly migraine days at run-in	6.54	6.94

Arms

Field	Verum STNS	Control
Intervention	Active supraorbital transcutaneous neurostimulation (STNS) using the Cefaly device applied daily for 20 minutes for 3 months	Sham supraorbital stimulation using the Cefaly device applied daily for 20 minutes for 3 months
Duration	3 months (daily 20-minute sessions)	3 months (daily 20-minute sessions)

Outcomes

Outcome	Type	Control	Intervention	P-value
Co-primary outcomes: (1) change in monthly migraine days from run-in (baseline) to month 3 of treatment; (2) 50% responder rate (percentage of subjects with ≥50% reduction in monthly migraine days)	Primary	Monthly migraine days: 6.22 (from 6.54 baseline); 50% responder rate: 12.1%	Monthly migraine days: 4.88 (from 6.94 baseline); 50% responder rate: 38.1%	Monthly migraine days verum: p=0.023; sham: p=0.608. 50% responder rate: p=0.023 (verum vs sham)
Monthly migraine attacks	Secondary	Not significantly reduced	Significantly reduced	0.044 (verum group)
Monthly headache days	Secondary	Not significantly reduced	Significantly reduced	0.041 (verum group)
Monthly acute anti-migraine drug intake	Secondary	Not significantly reduced	Significantly reduced	0.007 (verum group)
Therapeutic gain (difference in 50% responder rate between groups)	Secondary		26% (38.1% - 12.1%)
Any adverse event	Adverse	0%	0%

Subgroup Analysis

Not reported in this poster abstract

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

Funding

Not explicitly stated in this poster abstract

Based on: PREMICE (The Journal of Headache and Pain, 2013)