Authors

Patients

Study protocol

Results

Gérardy et al. [14]

MO (n = 10)

Pilot 3-month open-label study

−1.3 days reduction in monthly attack frequency

Five out of ten patients satisfied

Schoenen et al. [15]

MO (verum = 34, sham = 33)

Multicenter, double-blind, randomized, sham-controlled 3-month study

≥50% responder rate: 38.1% in the verum group, 12.1% in the sham group

Russo et al. [17]

MO (n = 20)

2-month open-label study

≥50% responder rate: 81%

Magis et al. [16]

MO (n = 2313) who rented the Cefaly® device for a 40-day period

Survey of prospective company registry on general population

54.4% satisfied and willing to purchase the device after a 58-day test

4.4% (n = 47) report adverse events (2.03%: local intolerance)

Di Fiore et al. [18]

CM (n = 19, of which 13 with MOH)

4-month open-label study

≥50% reduction in monthly migraine days: 35%

Vikelis et al. [19]

Migraine patients (MO = 31, CM = 6) not responding or intolerant to topiramate

Multicenter, 3-month open-label study

≥50% responder rate: 1 out of 31

−2.6 headache days

−3.9 days with acute medication

Przeklasa-Muszynska et al. [20]

CM (n = 58)

3-month open-label study

≥50% reduction in attack frequency

Decrease in intensity and duration

In a sham-controlled, double-blind randomized trial (the PREMICE trial) [15], Cefaly® was used for episodic migraine prophylaxis [3]. After 3 months of treatment (one 20-min session/day), in the 34 patients randomized to the verum group, there was a reduction in the average number of days with migraine from 6.94 to 4.88 compared to a change from 6.54 to 6.22 of the sham group (n = 30), a higher percentage of 50% responders (38.2% vs. 12.1%, i.e., a therapeutic gain of 26.1%). This therapeutic effect was accompanied by a reduction in the average number of triptans taken per month. Considering the number needed to treat (3.8) [21], efficacy was comparable to that of the most effective preventive drug treatments like topiramate (NNT: 3) [22]).

Thanks to an in-built software, the Cefaly® can record information on the use the patient has made of the device. By virtue of this technical characteristic, it was possible to study compliance in over 2000 patients treated from September 2009 to June 2012 in whom adverse events, degree of satisfaction with the device, and willingness to pay for it were also monitored [16]. Only 4.3% of enrolled patients reported at least one adverse event during treatment with eTNS, none of them serious and all reversible. The most frequent reported adverse event was intolerance toward the sensation of paresthesia induced by electrical stimulation, which led, in some cases, to treatment interruption. Other adverse events were somnolence during treatment, tension-type headache, and reversible irritation of the forehead skin. Of the total patients, 53.4% said they were satisfied with eTNS and willing to pay for it after a 40-day test period. The degree of satisfaction increased (55.5%) if patients (n = 48) who actually had never switched on the device were excluded from the calculation [16].

In an open-label study, De Fiore et al. [18] first treated 19 consecutive chronic migraine patients (68.4% with medication overuse) from three headache centers with daily session of eTNS taken at home for 4 months. About 35% of patients achieved a mean reduction in headache days of 57.9% and a mean reduction in drug consumption of 68.8%.

10.2.2 Acute Treatment

Although the Cefaly® comprises a stimulation program for the treatment of migraine attacks since it is on the market (frequency of 100 Hz, maximum intensity of 16 mA), only limited data is available right now on the efficacy of acute treatment of migraine (see Table 10.2). In a pilot study published in abstract form, ten episodic migraine patients treated their attacks using the acute protocol of the Cefaly® device: total relief was reported in 12% of attacks, partial relief with rescue medication in 42.5%, and no effect in 45.5% [14]. In another open-label study, Cefaly® showed its efficacy as rescue therapy up to 3 days since the beginning of an attack, reducing headache severity by 46% [23]. From a recent online survey on 413 regular device users for migraine prevention, 88.6% also used it as an acute treatment in approximately 72% of their attacks, of which 42.6% were accompanied by reduced intake of headache medications [25].

Table 10.2

eTNS studies using the Cefaly® device for acute migraine treatment

Authors	Patients	Study protocol	Results
Gérardy et al. [14]	MO (n = 10): 3 attacks treated	Pilot open-label study	Attack outcome at 30 min: 12% total relief 45% partial relief 43% no effect
Kozminski [23]	MO (n = 16)	Open-label study Rescue for attacks of ≥72 h	46% partial relief 56% patients like to use it again
Chou et al. [24]	MO (n = 30)	Open-label study	After the 1-h treatment session: 57.1% mean pain intensity reduction 77% of patients with 50% pain relief No patients took rescue medication
Penning and Schoenen [25]	MO (n = 413): 3 attacks treated	Internet survey by questionnaire	88.6% use the device during attacks 42.6% device-treated attacks with reduction of acute migraine drug consumption
Chou et al. [26]	Migraine patients (n = 106, 23% with aura: 52 verum, 54 sham)	Multicenter, double-blind, randomized, sham-controlled In-hospital 1 h Attack duration ≥3 h	At 1 h: 59% mean pain intensity reduction (30% on sham) 63% ≥ 50% pain relief (sham: 31%) 29% pain-free (sham: 6%)
Mann and Schoenen [27]	MO (n = 48)	Open-label, at home, 2 h moderate to severe attacks of ≤4 h duration	At 2 h: 70.8% pain relief 35.4% pain-free 23% 2–24 h sustained pain freedom

MO episodic migraine patients

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