A new hand-held device that delivers a magnetic pulse to the back of the head could be a promising non-invasive, non-drug treatment option for patients with migraine. The device offers effective pain relief for up to 48 hours after treatment in some patients with migraine with aura*, without any serious side-effects, when given at the onset of symptoms, finds an Article published Online First and in the April edition of The Lancet Neurology.
Evidence suggests that single-pulse transcranial magnetic stimulation (sTMS)** might disrupt the electrical events in the brain that underpin migraine aura. Previous small studies suggest that sTMS reduces migraine pain and that it is well tolerated. However, previous trials used large and expensive devices not suitable for use outside a clinic, and patients were not masked to treatment making it difficult to confirm if the effect of TMS was real.
To address these limitations, Richard B Lipton from the Albert Einstein College of Medicine, New York, USA, and colleagues did a randomised, sham-controlled trial*** to assess the safety and effectiveness of a new, hand-held sTMS device suitable for home use, in the treatment of migraine with aura. 201 patients were randomly assigned to sham stimulation (99) or sTMS (102) and instructed to treat up to three attacks over 3 months while experiencing aura, and to record pain and associated symptoms before and at regular intervals after treatment.
Findings showed that sTMS was significantly more effective than placebo for the treatment of migraine with aura. More patients were pain free at follow-up intervals of 2, 24, and 48 hours, were free of headache recurrence, and did not require rescue medication, compared with sham stimulation. Of the 164 patients who treated at least one attack, 39% in the sTMS group were pain free 2 hours after treatment compared with 22% in the sham group, a therapeutic gain of 17%.
Additionally, sTMS treatment did not exacerbate associated symptoms, and was non-inferior to sham stimulation for the improvement of nausea, photophobia (excessive sensitivity to light), and phonophobia (heightened sensitivity to sounds).
Importantly, sTMS treatment was well tolerated and no device-related serious adverse events were reported, while incidence and severity of side-effects was low and similar between the two groups. Furthermore, patients rarely experienced errors when using the device and rated it an average 8 out of 10 for user-friendliness.
The authors comment: "Although the exact mechanisms of migraine remain under study, administration of sTMS in people with migraine with aura decreases progression of the attack in some individuals…and could be a promising acute treatment."
They conclude by saying that more research is needed to examine the range of sTMS doses and to establish the optimum timing of treatment and cost effectiveness.
In an accompanying Comment, Hans-Christoph Diener from University Hospital Essen in Germany says that these findings show that: "the use of TMS could be a major step forward in the treatment of migraine with aura, particularly in patients in whom presently available drug treatment is ineffective, poorly tolerated, or contraindicated."
Contact: Dr Richard B Lipton, the Albert Einstein College of Medicine, New York, USA. T) +1 718 430 3101 (Deirdre Branley, Albert Einstein Department of Communications and Public Affairs) E) rlipton@aecom.yu.edu
Dr Hans-Christoph Diener University Hospital Essen, Essen, Germany. T) +49 201 723 2460 E) h.diener@uni-essen.de
For full Article and Comment, see: http://press.thelancet.com/migraine.pdf
Notes to Editors:
*There are two major types of migraine: migraine without aura, and migraine with aura. In migraine with aura, a variety of focal neurological features occur in association with the headache, usually beginning before the onset of pain. These include visual symptoms such as spots of light, zigzag lines, and regions of visual loss, as well as non-visual symptoms including tingling and numbness, and weakness and difficulties with language.
**There are two types of TMS: single pulse (sTMS), and repetitive TMS (rTMS). In sTMS, used in the present study, individual magnetic pulses are applied. In rTMS a series of pulses is used. rTMS has been approved by regulatory bodies for use in diagnostic testing and for the treatment of depression. There is therefore a large body of data supporting the safety of TMS with much higher exposures than used in the present study. The device used in this study is portable and suitable for self-treatment outside medical settings.
*** The trial involved an identical device designed to deliver an inactive (sham) impulse to ensure patients and investigators were masked to treatment. Both active and sham treatment was associated with a clicking sound and vibration of the device to maintain blinding. Blinding was successful as demonstrated by the fact that 80% of patients in both groups thought they received active sTMS.
Journal
The Lancet Neurology