“Hope for migraine sufferers as gadget that zaps pain with the push of a button is approved,” says the Mail Online, reporting a newly approved magnetic therapy.
The widespread media coverage follows the publication of new guidance from the National Institute for Health and Care Excellence (NICE) on the use of a device that gives magnetic pulses for the prevention and treatment of migraines. This type of therapy is called transcranial magnetic stimulation (TMS).
What is TMS and how does it work?
TMS stands for transcranial magnetic stimulation. The treatment involves the person holding a device on their scalp that then delivers a magnetic pulse through the skin. The device is portable and can be used at home or wherever is convenient.
The number of pulses can be changed – from a single pulse (sTMS) to repeated pulses (rTMS). The strength, frequency and length of time it is given can also be varied for each individual. The device records the treatments, which can be useful as part of a headache diary.
Migraines are severe headaches that are usually accompanied by additional symptoms including nausea and vomiting, and aversion to light and sound. A migraine may or may not be preceded by a warning “aura” where the person may experience visual changes such as seeing flashing lights or zigzag lines or other symptoms.
The cause of migraines is not known, but involves sudden contraction and then dilation of blood vessels in the brain. Numerous triggers have been identified including changes in hormone levels, environment (such as bright lights), diet and emotions.
NICE reports that TMS can be used in people who experience migraine with or without aura. It is not fully understood why delivering TMS can reduce the severity or frequency of migraines in some people.
Many media reports talk of the pulses “short-circuiting” the “electrical storms” of a migraine. Such terms are fanciful and unhelpful. All we can say with certainty is that we know that some people with migraines find TMS helpful. It is unclear why this is the case.
TMS is not a cure for migraine. Evidence from clinical trials has shown that it can reduce the severity or frequency of attacks in some people, but may not be effective for others. In a multicentre randomised controlled trial of TMS in 164 people who had migraine with aura:
- 39% of the patients were pain-free two hours after stimulation compared with 22% of patients using a placebo (control)
- 29% were still pain-free after 24 hours with no recurrence of migraine or need for medication, compared with 16% using placebo
What recommendations do NICE make about the use of TMS?
NICE has recommended that TMS can be used in two different ways:
- when a migraine starts, to treat or reduce the severity of the migraine
- using it regularly to prevent or reduce the frequency of migraines occurring
As this is a new treatment option, with limited evidence of long-term effects, NICE recommends that it is only provided by headache specialists and that they keep a record of each patient experience to broaden the knowledge base on its effectiveness.
Usual treatments for migraine can be given at the same time, including triptans (specific drugs licensed for the treatment of migraine, including sumatriptan, brand name Imigran), painkillers and anti-sickness drugs. TMS also does not interfere with other treatment options, which include nerve blocks, Botulinum toxin type A injections (Botox) or acupuncture.
It could be the case that TMS could serve as part of a combination therapy for some people rather than a single, standalone treatment.
Are there any safety concerns/side effects?
During the small clinical trials, one or two people reported side effects including:
- slight dizziness
- muscle tremor causing difficulty in standing
- vigorous dreams
- phonophobia (fear of loud sounds)
The specialist advisers to NICE reported some patients experiencing momentary muscle spasm, pain where the TMS is given, and hearing difficulty during TMS.
The specialist advisers listed the following potential side effects of TMS, though none have been reported yet:
- local scalp irritation
- mood disorders
- cognitive impairment
- triggering of epilepsy during treatment
- “kindling” leading to seizures
How accurate is the media’s reporting of the guidelines?
In general the media has reported this story accurately and responsibly – pointing out that although this treatment has been approved, there are only limited trials showing its effectiveness and no long-term trials. However, the Daily Express has inaccurately reported pulses “destroying neurons in the brain” and has wrongly described TMS as an NHS device. The NHS does not manufacture TMS devices.