Friday February 8 2013
The device works by stimulating nerves with electricity
The Mail Online has asked whether a ‘Star Trek’ style headband could ‘help banish migraines’. The device, worn on the forehead, is a futuristic-looking metallic headband and based on a small study, may indeed be able to help migraine sufferers.
The Mail reports on a well-conducted, if relatively small, trial comparing the effectiveness of a new electrical device for migraine prevention with an identical ‘sham’ device.
The device – known as a supraorbital transcutaneous stimulator or STS – is stuck to the forehead and delivers electrical stimulation to the nerves around the eyes and forehead.
Researchers found that people who wore the device experienced about two fewer migraine days per month – a reduction that was not seen in the sham group. However, differences between the two groups were only slightly significant.
The device also significantly improved the proportion of people who had at least 50% fewer migraines per month. No side effects of the STS treatment were observed, which is potentially significant because many drug treatments of migraine can cause side effects. However, studies in many more people would be needed to confirm that STS definitely caused no side effects.
Overall, this is a well-conducted trial with promising early results.
Where did the story come from?
The study was carried out by researchers from the Headache Research Unit at Liège University and other institutions in Belgium and was funded by the Walloon Region. The devices were provided by the Belgium company, STX-Med. For those readers of a more cynical bent, it appears that none of the investigators had any financial interest in either the device or STX-Med.
The study was published in the peer-reviewed journal Neurology.
The Mail Online’s reporting of the findings was accurate and representative of this study. However, the appearance of the device pictured and described on the website differs from the image of the device in the research paper.
In the research paper the device was part of an adhesive strip placed on the forehead. However, the images in the Mail story do correspond with images on the manufacturer’s website. It could simply be the case that there are different models or styles of the device.
What kind of research was this?
This was a randomised controlled trial (RCT) testing the safety and effectiveness of a device designed to prevent migraine, compared with a sham device.
The device is called a ‘supraorbital transcutaneous stimulator’ (STS) which is positioned around the forehead and is designed to stimulate the trigeminal nerve through the skin.
The trigeminal nerve is one of the main nerves of the face and has three main branches – the first going into your forehead and around your eyes, the second going into your cheeks, and the third going into your jaw. These nerves transmit sensations from the face to the brain. This device is designed to stimulate the first (ophthalmic) branch of the trigeminal nerve.
Migraine is a severe headache that is often accompanied by nausea and vomiting and an aversion to light and sound. Migraine with aura is when the headache is preceded by neurological symptoms, most often visual symptoms, such as seeing flashing lights.
As the researchers say, stimulating the facial nerves has long been considered potentially beneficial for treating headaches. In an initial pilot study involving 10 people who have migraines, this new STS device was found to be of benefit. This new research followed on from this by conducting a trial in a larger group of people who have migraines.
An RCT comparing the device with an identical sham device is the best way to see if it is safe and effective. However, more research using far more people, over longer periods of time, is needed to properly assess the device’s safety and effectiveness.
What did the research involve?
The study was conducted in five specialist headache clinics in Belgium. People were eligible for the study if they were adults (aged between 18 and 65 years old) who experienced migraine, with or without aura, and had at least two migraine attacks in the month before the start of the trial.
The researchers excluded people who had taken preventive treatments (such as beta blockers or amitriptyline) for migraine over the past three months, or who in the past had failed to respond to at least three conventional migraine treatments.
The STS device and the sham device were identical. Each consisted of a 30mm by 94mm self-adhesive electrode placed on the forehead, covering the top of the bridge of the nose and above both eyes. The STS delivers electrical impulses over sessions lasting 20 minutes. Both the STS and the sham device buzzed identically during treatment, and instructions for use were the same.
The treatment period was 90 days, with an assessment halfway through at 45 days. Participants filled diaries recording when their headaches occurred and how severe they were. This severity was recorded using a 4-point scale:
- 0 – no pain
- 1 – mild and not interfering with normal daily activities
- 2 – moderate, interfering with daily activities
- 3 – severe pain prohibiting daily activities
Participants were also asked to record whether the migraine was associated with symptoms of aura, nausea/vomiting, or aversion to light or noise and to say whether they used any pain-relieving medication.
The researchers’ main outcome measures were:
- change in monthly migraine days from before the trial to 90 days
- the proportion of people with response as defined by at least 50% reduction in monthly migraine days
Other outcomes included other measures of the headache and participant satisfaction with the device.
What were the basic results?
The trial included 67 people, 34 in the STS group and 33 in the sham group. The trial was completed by 30 and 29 people respectively, but everyone who started the trial was included in the final statisctical analyses.
By 90 days researchers found that people using the STS device experienced a significant, 30%, reduction in the number of migraine days (from 6.9 days before treatment to 4.9 days after treatment). In the sham group there was a 5% difference in migraine days (from 6.5 before treatment to 6.2 after treatment). However, the actual difference between the two groups was only of borderline clinical significance.
For the other main outcome examined, the STS device significantly improved (by 38%) the proportion of people achieving a response (at least 50% reduction in monthly migraines days). Just 12% of the sham group experienced a >50% reduction in monthly migraines days.
People using the STS device also had fewer total migraine attacks, fewer days with headache, and used fewer pain relief medications each month. However, it did not improve severity of migraines. Satisfaction with treatment was also higher in the STS group (70.6%) than the sham group (39.4%). There were no reported adverse effects in either group.
How did the researchers interpret the results?
The researchers conclude that their study provides high-level evidence that treatment with a supraorbital transcutaneous stimulator (STS) is effective and safe as a preventive therapy for migraine.
While this news may seem like something out of science fiction, it appears that there is indeed some cause to think that a device looking similar to that worn by Star Trek’s Geordi La Forge (pictured above) could have the potential to be used by people who have migraines.
This news story is based on a well-designed study that benefits from using identical STS and sham devices. It also benefits from having a high follow-up rate and the fact that neither participants nor investigators were aware of which treatment each person used.
The study demonstrates that the STS had some effect in improving the main outcomes that it set out to examine. It improved the number of migraine days per month, and the proportion of people who responded as defined by at least 50% reduction in monthly migraine days. There was also some benefit on other outcomes and no observed safety effects.
However, further study of this device will be needed to confirm it is safe and effective and to see who would most benefit from treatment.
So far, relatively few migraine sufferers (67) have been studied and the use of the device has only been examined over three months. Longer-term treatment in much larger numbers of people (ideally hundreds or thousands) would be needed to confirm that this device is safe, particularly if it is used daily for long periods of time.
Safety, effectiveness, acceptability, and convenience (particularly considering it is a device worn on the forehead) would also need to be compared to standard medical treatments currently used for migraine prevention.
Overall, this is a well-conducted trial, but more research is needed.
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.