Six million migraine sufferers living in the UK have today been given a new treatment hope with National Institute for Health and Care Evidence (NICE) backing for a new magnetic pulse procedure.
Following a review of available evidence, which it notes remains limited, NICE’s Interventional Procedures Advisory Committee has concluded that Transcranial Magnetic Stimulation (TMS) - a non-invasive procedure designed to treat or prevent migraine episodes in people with acute or chronic migraine - is safe and effective.
The Institute has not, however, made any recommendations on funding for the procedure, effectively leaving that decision to local clinical commissioning groups, as its interventional procedures guidance only covers the safety of the procedure, whether it works well enough for routine use, and whether any special arrangements are needed for patient consent.
Along these lines, NICE has stressed that doctors should put “special arrangements” in place for clinical governance, patient consent and audit or research if they want to use TMS, which means that they should take "extra care to explain the risks to patients and put in place extra steps to record and review what happens," a spokesperson told PharmaTimes World News.
TMS is administered via a tabletop or handheld device that delivers a predetermined, variable level of magnetic pulse or pulses to the head.
In one clinical trial data involving 164 patients, those treated for at least one attack of migraine with aura with a handheld sTMS device experienced significantly better pain-free rates two hours after the procedure than those receiving a 'sham' stimulation (39% versus 22%, respectively).
A significantly greater number of patients were also found to be pain-free (with no recurrence and no rescue drug use) at 24 hours (29% vs 16%, respectively) following treatment.
And on the safety side, no device-related serious adverse events were reported in the trial, NICE noted.
Migraine affects around 10% of adults, but despite the availability of current treatments - such as painkillers, antiemetics, tritons, nerve blocks, Botox and acupuncture - there still remains a significant unmet need for patients.
According to The Migraine Trust, in Britain there are around190,000 migraine attacks every day and 25 million days lost from work or school each year, and it notes that the device may prove particularly appropriate for patients who find other treatments ineffective, or unsuitable, such as during pregnancy.
“This is a breakthrough treatment for those who cannot tolerate or do not respond to current treatment, and opens the door for a new era in treating migraine headaches," noted Consultant neurologist Fayyaz Ahmed, a trustee of The Migraine Trust.
Nevertheless, given the limited amount of long-term safety data available for the procedure, NICE has recognised the need for more research on magnetic stimulation of the brain to prevent and treat migraine.