This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A multicentre randomised controlled trial of 164 patients treated for at least 1 attack of migraine with aura with a handheld single transcranial magnetic stimulation (sTMS) device (n=82) or with sham stimulation (n=82) reported that pain-free rates 2 hours after stimulation were significantly better with sTMS (39% [32/82]) than with sham stimulation (22% [18/82]; p=0.018). Sustained pain-free response rates (with no recurrence and no rescue drug use) significantly favoured sTMS at 24 hours (29% [24/82] versus 16% [13/82]; p=0.0405) and 48 hours (27% [22/82] versus 13% [11/82]; p=0.0327) after treatment. There were no significant differences in secondary outcomes (headache response at 2 hours, use of rescue drugs, Migraine Disability Assessment [MIDAS] score and consistency of pain relief response) between groups.
4.2 A case series of 51 patients with 'medically resistant migraine' using repeated transcranial magnetic stimulation( rTMS) for prevention reported that 98% (50/51) of patients had a greater than 50% reduction in headache frequency at the end of 1 week and the improvement persisted at follow-up of 4 weeks in 80.4% (41/51) of patients. Headache frequency and severity, functional disability and use of rescue drugs were significantly reduced at all time points (1, 2, 3 and 4 weeks, p<0.0001) but the maximum benefit was observed in the first 2 weeks.
4.3 A case series of 27 patients with migraine comparing low-frequency rTMS (n=14) against sham stimulation (n=13) for prevention reported no significant difference between groups for any reported outcome (including number and duration of migraine attacks, mean pain intensity and use of analgesics). The 'within-group' findings showed a significant decrease in the number of migraine attacks during 8 weeks within the rTMS group from 9.36±2.82 attacks to 6.79±4.28 attacks (p=0.007), and a non-significant decrease within the sham group (numbers not reported; p=0.216). There was a significant reduction in migraine days during 8 weeks in both rTMS and sham groups (from 17.69±11.63 days to 13.15±9.27 days [p=0.012] and from 14.36±5.07 days to 9.50±6.80 days [p=0.006] respectively). The rTMS group showed a significant reduction in migraine hours during 8 weeks from 125.93±80.31 hours to 85.36±72.27 hours (p=0.035); the difference was not significant in the sham group (numbers not reported; p=0.080).
4.4 The specialist advisers listed additional efficacy outcomes as complete resolution of a migraine attack, reduction in headache severity, and improvement in associated symptoms, disability and quality of life.