A pioneering treatment for restless legs syndrome – an agonising condition that can leave sufferers unable to sleep – could soon be available in Britain, the Daily Mail can reveal.
The device, which is already being used by thousands of patients in the US, delivers mild electrical pulses to nerves in the legs, significantly easing symptoms without the need for medication.
Strapped just below the knees for 30 minutes at a time, it offers patients relief while lying in bed.
In a recent study involving more than 200 patients whose symptoms had not been adequately controlled by medication, nearly 80 per cent experienced a clinically meaningful improvement.
And now the manufacturer Noctrix Health has confirmed to the Daily Mail that it is ‘in discussions’ about bringing the device, called Nidra, to the UK.
Experts say it could offer a lifeline to patients who have exhausted existing treatments, some of which can cause disturbing side effects, including gambling addiction, obsessive sexual desires and suicidal thoughts.
Restless legs syndrome affects up to one in ten people and is more common in women
‘For people who are at the severe end of things, even a move back to moderate symptoms is a bonus because at the severe end, the impact on people’s lives is enormous,’ says Dr Julian Spinks, a GP and chair of RLS-UK.
‘At the severe end, people clutch at straws and they try everything. If you are severe enough that you spend most of every night awake, it’s difficult to know how you get round that the next day when you’re tired.’
Why is restless leg syndrome so difficult to treat?
Restless legs syndrome, or RLS, affects up to one in ten people and is more common in women.
It causes an unpleasant ‘crawling’ sensation in the legs, usually at night, along with an almost irresistible urge to move them.
In the worst cases, it can severely interrupt sleep, damage mental health and ruin relationships and careers.
RLS is thought to be linked to the way the brain uses dopamine, a chemical involved in movement. Doctors are still unsure what triggers it.
Historically, treatment options have been limited, with many coming with unpleasant side effects.
Doctors often advise lifestyle measures such as reducing caffeine and alcohol intake, treating iron deficiency and maintaining good sleep habits.
However, many patients eventually require medication and some continue to experience symptoms despite treatment.
For decades, people suffering from chronic RLS have been treated with drugs called dopamine agonists, which mimic the effects of natural dopamine.
But mounting evidence has shown that these medicines, while effective, can trigger disturbing side effects due to the way they alter brain chemistry.
These include triggering psychiatric changes, including gambling addiction, obsessive sexual desires and even suicidal thoughts.
Doctors have become increasingly cautious about long-term use of dopamine agonists because they can trigger a phenomenon known as augmentation, in which symptoms become more severe and start earlier in the day.
Other treatments include nerve drugs, such as gabapentin and pregabalin, that can calm nerve signals, and low-dose opioids.
However, experts say there are countless patients who are not receiving effective treatment.
The Nidra device is pictured. It works by stimulating the same nerve pathways involved in leg movement, allowing patients to receive relief while remaining in bed
Studies show about one in five sufferers are classed as ‘severe’, meaning their symptoms regularly disrupt their lives.
Meanwhile, about a fifth do not respond to any drug treatments.
How does the new device work – and how effective is it?
The idea behind Nidra stems from a well-known feature of RLS: symptoms often improve when sufferers get up and walk around.
The gadget works by stimulating the same nerve pathways involved in leg movement, effectively mimicking some of the nerve activity associated with walking.
Patients can activate it when symptoms flare up, receiving treatment while remaining in bed.
In the latest study of the device, published this year, 232 patients whose RLS had not been adequately controlled by medication were given Nidra to use when they experienced flare-ups.
Their sleep quality improved and the number of days patients experienced symptoms fell from 6.1 to 4.8 a week.
Researchers also found average symptom scores improved by 8.4 points, while almost 80 per cent of participants achieved what doctors consider a clinically meaningful benefit.
Significantly, nearly one in five participants reduced their current medication without worsening symptoms.
Reported side effects were generally mild, including skin irritation and discomfort.
However, the study did not include a placebo group, meaning it cannot prove that all of the benefit was due to the device.
Nidra has already been used by more than 6,500 patients in the US, where it is sold for about £6,000.
According to Noctrix Health, around 80 per cent of users report noticeable symptom relief within 30 minutes of activating the device.
‘What makes nerve stimulation interesting is that it offers a non-drug option,’ says Dr Muhammad Qasim, a sleep medicine expert.
‘That matters because gabapentin-type medications can cause dizziness or sleepiness, while long-term dopamine agonists can sometimes produce augmentation, where RLS symptoms actually become earlier, stronger, and more widespread.’
Dr Spinks says he hopes the device will eventually be available on the NHS.
‘I’d love to have it available to be prescribed by GPs, but I suspect it is more likely to be something patients would initially need to access through specialist clinics.’
Any future NHS rollout would depend on regulatory approval, NICE assessment and price negotiations.
Jonathan Charlesworth, co-founder and chief scientific officer of Noctrix Health, said: ‘The burden of RLS in the UK is similar to that in the US and there remains significant unmet need.
‘People often describe feeling trapped by their symptoms and unable to sleep.
‘Having a predictable way to control symptoms can help patients feel they are back in control of their condition rather than the condition controlling them.
‘Many patients report relief within 30 minutes, and being able to get that relief while lying in bed rather than getting up to walk around is particularly valuable.
‘It is a solution people can use indefinitely for the rest of their lives.’
The company could not give a timeline for when Nidra might become available in Britain.
What are patients saying?
Patients in the US who have tried Nidra have described dramatic improvements in their symptoms, with some saying the device has transformed their lives.
One sufferer, Rick, who has lived with severe RLS for decades, said the condition had ruined much of his retirement, making it difficult to travel with his wife or get a decent night’s sleep.
Writing on an online discussion board run by the US-based Restless Legs Syndrome Foundation, under the username Stainless, he described how he initially experienced mixed results after starting Nidra in September last year, but began noticing consistent improvements after about seven weeks.
He has since enjoyed a three-week Mediterranean holiday and reported being able to sleep comfortably again.
He called Nidra ‘the best thing that has happened to me in ten years’.
Another patient, writing on the RLS-UK online community forum HealthUnlocked, described how the device had transformed their nights.
‘Last night I turned on the Nidra bands and slept the entire night without waking up,’ they wrote, although they were also taking medication for the condition.
However, not everyone experiences immediate relief. Some patients posting on the RLS discussion board describe inconsistent results, while others, including Rick, continue to need medication alongside the device.
What can sufferers do in the meantime?
While Nidra is not yet available in Britain, specialists say there are several ways patients can ease their symptoms.
One of the most important is checking iron levels. Research suggests that insufficient iron in the brain may play a significant role in RLS – and patients can have levels low enough to worsen symptoms even if they are not technically anaemic.
US guidelines published last year recommend blood tests to check iron stores, with supplements or intravenous iron infusions offered to some patients. However, iron should only be taken following medical advice, as excessive amounts can be harmful.
Regular exercise may also help. In one small clinical trial, patients who followed a 12-week programme of aerobic exercise and resistance training experienced significantly greater improvements than those who did not exercise.
According to RLS-UK, cutting back on caffeine and alcohol, maintaining regular sleep patterns and avoiding prolonged periods of sitting still may also help.
Some sufferers find temporary relief from stretching, massage, warm baths or short walks, although scientific evidence supporting these measures is limited.
Other devices, including vibrating pads and compression wraps, are already available privately, but evidence for their effectiveness varies.
Patients with persistent symptoms should speak to their GP, as RLS can sometimes be linked to underlying conditions such as kidney disease or pregnancy, while certain medications, including some antidepressants and antihistamines, can make symptoms worse.
