Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013 Feb 19;80(8):697-704. Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gérard P, Magis D.
Abstract OBJECTIVE: To assess efficacy and safety of trigeminal neurostimulation with a supraorbital transcutaneous stimulator (Cefaly, STX-Med., Herstal, Belgium) in migraine prevention. METHODS: This was a double-blinded, randomized, sham-controlled trial conducted at 5 Belgian tertiary headache clinics. After a 1-month run-in, patients with at least 2 migraine attacks/month were randomized 1:1 to verum or sham stimulation, and applied the stimulator daily for 20 minutes during 3 months. Primary outcome measures were change in monthly migraine days and 50% responder rate. RESULTS: Sixty-seven patients were randomized and included in the intention-to-treat analysis. Between run-in and third month of treatment, the mean number of migraine days decreased significantly in the verum (6.94 vs 4.88; p = 0.023), but not in the sham group (6.54 vs 6.22; p = 0.608). The 50% responder rate was significantly greater (p = 0.023) in the verum (38.1%) than in the sham group (12.1%). Monthly migraine attacks (p = 0.044), monthly headache days (p = 0.041), and monthly acute antimigraine drug intake (p = 0.007) were also significantly reduced in the verum but not in the sham group. There were no adverse events in either group. CONCLUSIONS: Supraorbital transcutaneous stimulation with the device used in this trial is effective and safe as a preventive therapy for migraine. The therapeutic gain (26%) is within the range of those reported for other preventive drug and nondrug antimigraine treatments. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that treatment with a supraorbital transcutaneous stimulator is effective and safe as a preventive therapy for migraine.
This is an interesting paper; this combined with peripheral nerve stimulation studies has changed my current protocol for migraine, cervicogenic and tension headache treatment. These authors were reading and relating their treatment to the same peripheral nerve stimulation studies I was. Like me, they think that research is applicable to transcutaneous stimulation, which avoids the expense and complication of surgery. It’s also interesting where we differ: my initial approach is acute reduction/elimination of headache pain during an attack with 12 minutes of treatment, while they looked at prevention secondary to a daily 20 minute treatment. They use the Cefaly headband device which was shown to be safe in over 2300 patients and was the subject of my last blog. They used parameters of up to 16 mA, at 250 uS, at 60 Hz. While the other paper discussed their findings regarding safety and satisfication, I think this one is more interesting as it gave harder numbers with regards to effectiveness.
How effective was it? At least moderately so for prevention of headaches. Both the TENS and placebo group had a decrease in monthly migraine headaches of about 20% after the first month but in the 2nd and 3rd month of treatment the sham group headaches started increasing more towards baseline while the TENS group continued to improve. At 3 months, total headache days had decreased 32% in the TENS group compared to 3% in the placebo group. Headache severity decreased 8% in the TENS group compared to 3% in the placebo group, and acute drug intake decreased 37% in the TENS group compared to increasing 1% in the placebo group.
Results were not as good as that shown with the surgically- implanted electrode studies. However, surgery was avoided and unlike the surgically-implanted stimulators complications were essentially nil. I still think they are missing something by doing only supraorbital (forehead) stimulation without also hitting the suboccipital (back of the neck) region. It’s still a great paper though, and based on my results with TENS/EMS for headaches the findings are certainly believable. I’ll be doing a follow-up blog comparing acute outcomes of the combined supraorbital and occipital stimulation to what I got with occipital nerve stimulation alone after I collect data on another 15 patients. So far, the results appear favorable.
As always, if you have any further questions or need for clarifications, please don’t hesitate to ask. Being aware that some of my blog ideas are contentious and occasionally a bit out of the field of my expertise, I encourage my readers to come forth with any questions/comments that are of interest or concern. Your comments are valued and welcomed.
Chad Reilly is a licensed physical therapist, located in North Phoenix, practicing science based medicine with treatment protocols unique and effective enough to proudly serve patients from Phoenix, Scottsdale, Mesa, Chandler, Tempe, Peoria, and Glendale.