Diagnosed with Crohn’s disease at 13, by the time she reached 25, schoolteacher Kelly Owens had given up all hope of living a normal life. The debilitating inflammatory bowel disease affects about 300,000 people in the UK, causing diarrhoea, extreme tiredness, stomach aches and weight loss.
There is no cure, but drugs such as steroids can reduce inflammation, and the condition may be partially relieved by surgery to repair or remove damaged parts of the digestive system.
Over the years, doctors had tried almost two dozen different drugs on Kelly, who says they ‘either didn’t work at all or my body would build up antibodies against them and they’d soon stop working’.
Kelly Owens, 30, volunteered in 2017 to be a guinea pig in a trial of a revolutionary technique that could offer a new treatment for dozens of diseases, including arthritis, asthma, diabetes and depression
Kelly wasn’t just battling the colitis — the inflammation and ulceration of the large intestine — that is the classic manifestation of Crohn’s. The condition had also triggered inflammatory arthritis that affected all her joints, even her jaw, as well as pyoderma gangrenosum, a skin condition that left her legs covered in agonising ulcers.
Just one steroid, prednisone, gave her any relief. ‘It was the only thing that helped me to function,’ says Kelly, now 30.
But prednisone reduces the amount of calcium in the blood and soon she was diagnosed with osteoporosis, a condition that weakens bones to the point where they can easily break.
‘Miracle’ may treat dozens of diseases
Kelly says that by the time she was 25, she was ‘in pretty bad shape’. But within three years her condition had improved beyond all recognition, thanks to what she describes as ‘a miracle’ — a miracle that countless other patients could one day be experiencing.
In 2017, Kelly volunteered to be a guinea pig in a trial of a revolutionary technique that could offer a new treatment for dozens of diseases, including arthritis, asthma, diabetes and depression. That decision has transformed her life.
It works by an electrical implant in the chest which activates the vagus nerve, which runs from the brain to the abdomen
Kelly is one of a handful of people worldwide to benefit from this revolutionary branch of medicine: bioelectronics. She now has a device the size of a matchbox implanted in her chest that sends messages to keep her immune system under control.
For her, it has been life-changing.
‘Before, I had to think about every movement I made,’ she says. ‘Now I just have this wonderfully normal life and I’m medication-free. I never imagined that 30 years old could feel so young.’
Our immune systems keep us healthy by fighting off infection or the effects of injury. But sometimes they go haywire, producing an overreaction that causes diseases including Crohn’s, diabetes, rheumatoid arthritis, Alzheimer’s and multiple sclerosis.
Diagnosed with Crohn’s disease at 13, by the time Kelly reached 25, she had given up all hope of living a normal life
Traditionally, drugs have been used to dampen down this response, but companies are now racing to develop what many believe will be a cheaper and more effective alternative, without any of the drugs’ side-effects.
Their hopes rest on tiny electronic devices implanted in the body to regulate the electrical impulses that control the inflammatory reflex of the immune system.
The father of bioelectronics is Professor Kevin Tracey, a neurosurgeon and inventor, now president and CEO of the Feinstein Institutes for Medical Research in New York.
In 2000, Dr Tracey published a paper in the journal Nature showing that inflammation in rats could be reduced by electronically stimulating the vagus nerve.
This is the longest nerve in the body, running from the base of the brain, then dividing into two before travelling through the neck, chest and abdomen. It works as a conduit for a host of vital functions, including controlling heart rate and body temperature.
Dr Tracey discovered that this nerve also carries information that regulates the immune system and inflammation — and that this ‘inflammatory reflex’ could be controlled by electrical stimulation. As he told Good Health: ‘We now know that specific nerves control specific molecular targets in the same way that drugs do.’
Drugs attach themselves to these targets (via ‘receptor’ proteins in or on cells) in order to block messages from the body that would otherwise trigger the cell to react in an undesirable way.
Ibuprofen, for example, works by interfering with the chemical messages that trigger inflammation and pain — but most drugs can’t be finely targeted and may have side effects.
‘Side effects and the expense are real barriers,’ says Dr Tracey. ‘And people forget to take them.’
Kelly had seen Dr Tracey being interviewed in 2014 about a new device he had invented to treat inflammatory diseases.
She recalls: ‘He was talking about it in the context of rheumatoid arthritis but I wondered if this could work for me.’ Kelly contacted Dr Tracey, who advised her that although his device was not then suitable, she should keep checking back as his team’s work progressed.
Finally, some hope for Crohn’s
In 2012, Kelly married Sean, her childhood sweetheart, and moved from New Jersey to Hawaii, to try to improve her health.
‘The harsh winters of New Jersey made it that much harder on my inflammatory arthritis, adding to the discomfort I was in,’ says Kelly. ‘My hope was that I’d find some relief in Hawaii, but the weather didn’t make much difference.’
Her job as a teacher became difficult as the condition continued to worsen. ‘I would really push myself to get through the day, and then I would come home, ice my legs to help with the pain and the ulcerated skin and basically stay on the couch until I had to do it all over again the next day.’
After two years, aged 26, she had to quit the job she loved as ‘the colitis was so bad that I lost about 30 lbs in a few weeks. From that point, I was completely debilitated and disabled’.
Kelly and Sean, who runs his own carpentry business, returned to New Jersey and, two years later, in 2017, her doctors delivered a bombshell. ‘They told me: “You’ve been on every drug that’s available. From now on, you’re going to be on high doses of prednisone,”’ recalls Kelly. ‘I was crushed.’ Then she remembered Dr Tracey.
She went online and discovered that SetPoint Medical, a company working with Dr Tracey’s research, had just begun recruiting for a trial to see whether bioelectronic medicine might be effective in treating Crohn’s.
The hitch was that the trial was being conducted in Amsterdam.
Without even knowing whether she’d be accepted on to the trial — she needed tests to find if the ulceration of her bowel was great enough to meet the study’s strict inclusion criteria — Kelly and Sean ‘sold everything that wasn’t nailed to the floor’ and went to Holland.
‘Our family and friends put together a fundraiser for us and we raised $16,000 (£12,250).’
On June 22, 2017, Kelly underwent a 45-minute operation under general anaesthetic to have the device inserted into her chest. This was connected by a wire to the vagus nerve in her neck.
Two weeks later, ‘they turned it on for the first time and my life improved almost immediately’, she says. That night, Kelly ‘forgot to take pain medication because I wasn’t in pain for the first time in I can’t even remember how long’.
A few weeks later, while getting dressed, she noticed her knees, previously swollen ‘like little cantaloupe melons’, were now a normal size.
A week after that, she and Sean were running late for an appointment and had to dash up two flights of stairs. ‘Usually it would take me a long time,’ says Kelly. ‘This day, I got to the top and looked around for Sean. I looked to the bottom of the stairs and he was staring up at me in awe.’
Kelly was one of 16 patients with Crohn’s, all of whom had failed to respond to drug treatment, who were implanted with a vagus nerve stimulation device at one of five European centres in 2017.
In June last year, SetPoint unveiled the results of the trial at the Digestive Disease Week conference in Washington.
At 16 weeks, more than 60 per cent of the patients had logged significant reductions in the effects of the disease, as assessed by the Crohn’s disease activity index, which measures abdominal pain, well-being and toilet habits.
According to this scale, a reduction of 70 or more points is regarded as clinically meaningful.
Eight of the trial patients, including Kelly, scored improvements of 100 points or more, while four found almost all their symptoms disappeared.
SetPoint has also carried out a pilot study in the U.S. on 14 patients with rheumatoid arthritis using a device, the MicroRegulator, implanted in the neck.
This generates electrical pulses ‘prescribed’ wirelessly by a doctor through an app. Patients recharge the generator using a wireless charger worn around their neck.
After 12 weeks, five out of ten patients with the device had ‘clinically meaningful’ improvement in symptoms, with two achieving remission. Not one of the four on sham stimulation showed any improvement. The devices are not yet approved for clinical use, but may offer hope to those with autoimmune diseases.
Waiting list is growing already
How bioelectronics is saving lives
Electrical implants were first used in medicine with cardiac pacemakers in patients in the late Fifties. Today implanted pulse generators connected by wires to the brain are used to control motor symptoms of Parkinson’s, such as tremors.
However, much of the excitement in this new field of bioelectronics is centred on the vagus nerve, the longest nerve in the body, which starts at the base of the brain, then divides into two branches that travel through the neck, chest and into the abdomen, down into the small intestine.
It’s described as the body’s communication highway — relaying messages from tissues and organs to the brain and vice versa, controlling everything from swallowing to heart rate and digestion, which explain its appeal as a tool in the treatment of diseases. Vagus nerve stimulation is already used to reduce the number and severity of seizures in epilepsy when drugs don’t work. It is also used in depression resistant to other therapies.
The new approach is revolutionary because it targets inflammation (see main story) and could help a wide range of acute and chronic diseases.
‘I get letters and emails from patients and parents of children who are suffering every day, but, of course, we can’t give them devices yet,’ says Dr Tracey. ‘I answer some of them myself — they bring tears to your eyes. But the demand is so overwhelming that we hired a patient who is now in remission to answer these emails for me.’
That patient was Kelly, who now works as director of education and outreach at The Feinstein Institutes. ‘Right now, we have more than 1,000 patients registered, with the whole gamut of inflammatory diseases, who are anxiously awaiting access to bio-electronic medicine,’ she says.
Dr Tracey says many diseases with inflammatory components may respond to this treatment. Likely candidates include asthma, diabetes and high blood pressure.
This isn’t the first time electronic stimulation has been used as a treatment (see box, below left), but this is the first technique that offers so many potential applications — thanks to the discovery by Dr Tracey that stimulating the nerve inhibits the production of a molecule called tumour necrosis factor, which communicates immune responses to cells.
This molecule is one of the key targets of drugs used to treat inflammatory diseases such as Crohn’s and rheumatoid arthritis.
Electronic stimulation of nerves may have applications beyond controlling the body’s inflammatory responses, as research under way into a treatment for high blood pressure hopes to prove.
A U.S. company, CVRx, has developed a device implanted under the collar bone that uses electrical impulses to activate the body’s ‘baroreceptors’ — pressure sensors on the main artery and nerve that monitor and control blood flow. The Barostim Neo device causes the brain to relax blood vessels, slow the heart rate and so lower blood pressure.
Perhaps not surprisingly, big names are now rushing to invest in bioelectronics, including Google and General Electric, as well as leading public bodies in the U.S. such as the National Institutes of Health. The British firm GlaxoSmithKline is also supporting more than 30 bioelectronic projects around the world.
In the UK, Qasim Aziz, a professor of neurogastroenterology at Queen Mary, University of London, and medical adviser to the charity Crohn’s & Colitis UK, is planning a study to examine the potential of bioelectronics for patients with inflammatory bowel disease.
He told Good Health that the Crohn’s disease trial Kelly was part of, though small, ‘raises the hope that such an intervention could have a promising impact on patients’ management for chronic and often severe conditions such as Crohn’s disease’.
He added: ‘[It’s] an exciting new approach that has the potential to benefit many patients.’
Dr Tracey is hopeful that the use of bioelectronic devices for the treatment of rheumatoid arthritis could be approved by the U.S. Food and Drug Administration ‘in as little as three or four years’.
If successful, approval for its use in other conditions could follow.
A spokesperson for the Medicines and Healthcare products Regulatory Agency, which is responsible for approving new drugs in the UK, said it does not approve medical devices itself but instead oversees ‘notified bodies’ authorised to ensure any new device conforms with regulations set out under the Medical Device Regulations 2002.
When they do, they earn a CE mark, which approves the device for use throughout Europe.
Two years on from her procedure, Kelly remains a great advert for the effectiveness of bioelectronic medicine. A colonoscopy carried out after the trial showed that 50 per cent of her once chronically inflamed colon had healed in less than four months.
‘I’m due a further examination this summer, but I continue to feel like a million bucks,’ she says.
She is, understandably, forever thankful to Dr Tracey.
‘He and his team put together the puzzle pieces that will change the course of medicine as we know it,’ she says. ‘I’m convinced that this is the new frontier.’
Hospital test to see if it can treat heart failure
Five hospitals in the UK, including the world-famous Harefield Hospital, are taking part in a trial involving 480 patients to test the effectiveness of the device in treating heart failure.
Another team, working with SetPoint and led by Professor Peder Olofsson at the renowned Karolinska Institute in Sweden, last year reported experiments on mice that suggested vagus nerve stimulation might help a range of ‘common and debilitating acute and chronic diseases’, including septic shock and cardiovascular disease. Professor Olofsson told Good Health that the work of his team ‘is focused on the immune system and inflammation, which plays a role in so many aspects of life’.
He adds: ‘In fact, most diseases have some kind of inflammatory component, from cardio-vascular medicine to Crohn’s, psoriasis — even cancer. Some cancers rely on inflammation to thrive.
‘So there’s a broad swathe of medicine that may benefit from these insights.’