Can an electrical match the size of a matchbox put an end to the misery of diabetes, asthma AND arthritis?
At the age of 13 she was diagnosed with Crohn’s disease, by the time she was 25, teacher Kelly Owens had given up all hope of a normal life. The debilitating inflammatory bowel disease affects around 300,000 people in the UK and causes diarrhea, extreme fatigue, abdominal pain and weight loss.
There is no cure, but drugs such as steroids can reduce inflammation and the condition can be partially alleviated by surgery to repair or remove damaged parts of the digestive system.
Over the years, doctors had tried nearly two dozen different medications on Kelly, saying that they “didn’t work at all or that my body would build up antibodies against them and they would stop working soon.”
Kelly Owens, 30, signed up in 2017 as a guinea pig in a trial with a revolutionary technique that could offer new treatment for dozens of diseases, including arthritis, asthma, diabetes and depression
Kelly not only fought the colitis – the inflammation and ulcers of the colon – that is the classic manifestation of that of Crohn’s. The condition had also caused inflammatory arthritis that affected all her joints, even her jaw, as well as pyoderma gangrenosum, a skin condition that covered her legs with painful sores.
Only one steroid, prednisone, gave her 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 break easily.
‘Miracle’ can 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 recognition, thanks to what she describes as “a miracle” – a miracle that countless other patients could ever experience.
In 2017, Kelly signed up as a guinea pig in a trial with a revolutionary technique that could offer new treatment for dozens of diseases, including arthritis, asthma, diabetes and depression. That decision has changed her life.
It works through an electrical implant in the breast that activates the vagus nerve, which runs from the brain to the abdomen
Kelly is one of the few people worldwide to benefit from this revolutionary branch of medicine: bio-electronics. She has now implanted a device the size of a matchbox in her breast that sends messages to control her immune system.
For her it was life-changing.
“I used to have to think about every move I made,” she says. “Now I just have a wonderful normal life and I am free from medication. I never thought 30 years old could feel so young. “
Our immune system keeps us healthy by fighting infections or the effects of injury. But sometimes they get confused and produce an overreaction that causes diseases, including Crohn’s, diabetes, rheumatoid arthritis, Alzheimer’s and multiple sclerosis.
At the age of 13 she was diagnosed with Crohn’s disease, by the time Kelly turned 25, she had given up all hope of a normal life
Traditionally medicines were used to dampen this reaction, but companies are now racing for what many believe is a cheaper and more effective alternative, without the side effects of the medicines.
Their hope rests on small electronic devices implanted in the body to regulate the electrical impulses that control the inflammatory reflex of the immune system.
The father of bio-electronics is professor Kevin Tracey, a neurosurgeon and inventor, now president and CEO of the Feinstein Institute for Medical Research in New York.
In 2000 Dr. Tracey an article in the journal Nature that showed that inflammation in rats could be reduced by stimulating the vagus nerve electronically.
This is the longest nerve in the body, which runs from the base of the brain and then divides it in two before traveling through the neck, chest and abdomen. It acts as a channel for a large number of vital functions, including controlling heart rate and body temperature.
Dr. Tracey discovered that this nerve also contains information that controls the immune system and inflammation – and that this “inflammatory reflex” can be controlled by electrical stimulation. As he told Good Health: “We now know that specific nerves control specific molecular targets in the same way as drugs.”
Drugs adhere to these goals (via “receptor” proteins in or on cells) to block messages from the body that would otherwise cause the cell to react in an undesirable way.
Ibuprofen, for example, works by disrupting chemical messages that cause inflammation and pain – but most drugs cannot be finely targeted and can have side effects.
“Side effects and costs are real barriers,” says Dr. Tracey. “And people forget to take them.”
Kelly had seen Dr. Tracey was interviewed in 2014 about a new device he had invented to treat inflammatory diseases.
She remembers: “He spoke 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 unsuitable at the time, she had to keep checking team work progressed.
Finally some hope for Crohn
In 2012, Kelly married Sean, her childhood sweetheart, and moved from New Jersey to Hawaii to improve her health.
“The harsh winters of New Jersey made it much harder for my inflammatory arthritis, which contributed to the discomfort that I found myself in,” says Kelly. “I was hoping to find some relief in Hawaii, but the weather didn’t matter much.”
Her job as a teacher became difficult as the situation deteriorated. ‘I would really push myself to get through the day, and then I would come home, freeze my legs to help with the pain and sore skin and basically stay on the couch until I had to do it again the next day. “
After two years, 26 years old, she had to quit her job she loved, because the colitis was so bad that I lost about 30 pounds in a few weeks. From that moment on I was completely weakened and disabled ‘.
Kelly and Sean, who run his own carpentry business, returned to New Jersey and two years later, in 2017, her doctors delivered a bomb. “They told me:” You have used every medicine that is available. From now on you will get high doses of prednisone, “Kelly recalls. “I was crushed.” Then she remembered Dr. Tracey.
She went online and discovered that SetPoint Medical, a company that works with Dr. Tracey, who had just started recruiting a study to see if bioelectronic drugs can be effective in treating Crohn’s.
The failure was that the trial was conducted in Amsterdam.
Without even knowing if she would be admitted to the trial – she needed tests to find out if the gut ulcer was large enough to meet the strict inclusion criteria of the study – Kelly and Sean ‘sold anything the floor was nailed and went to Holland.
“Our family and friends have set up fundraising for us and we’ve raised $ 16,000 (£ 12,250).”
On June 22, 2017, Kelly underwent a 45-minute operation under general anesthesia to have the device inserted into her chest. This was connected via 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 was not in pain for the first time, I can’t even remember how long.”
A few weeks later, while dressing, she noticed that her knees, previously swollen “like small melon melons,” were now of normal size.
A week later, she and Sean were late for an appointment and had to run up two flights of stairs. “Normally it would take a long time,” says Kelly. “Today I went to the top and searched for Sean. I looked down at the bottom of the stairs and he stared at me in awe. “
Kelly was one of 16 patients with Crohn’s, all of whom had not responded to drug therapy, who had been implanted in one of the five European centers with a vagus nerve stimulation device in 2017.
In June last year, SetPoint unveiled the results of the trial at the Digestive Disease Week conference in Washington.
After 16 weeks, more than 60 percent of patients had registered significant reductions in the effects of the disease, as judged by the Crohn’s Activity Index, which measures abdominal pain, well-being and toilet habits.
According to this scale, a reduction of 70 or more points is considered clinically meaningful.
Eight of the test patients, including Kelly, scored improvements of 100 points or more, while four discovered that almost all of their symptoms had disappeared.
SetPoint has also conducted a pilot study in the US on 14 patients with rheumatoid arthritis using a device called the MicroRegulator implanted in the neck.
This generates electrical pulses wirelessly ‘prescribed’ by a doctor via an app. Patients charge the generator with a wireless charger that is worn around their neck.
After 12 weeks, five out of ten patients with the device had a “clinically meaningful” improvement in symptoms, with two achieving remission. None of the four on sham stimulation showed any improvement. The devices are not yet approved for clinical use, but can offer hope to people with autoimmune diseases.
The waiting list is already growing
How bioelectronics saves lives
Electric implants were first used in medicine with pacemakers in patients in the late 1950s. Today, implanted pulse generators connected to the brain via wires are used to control Parkinson’s motor symptoms, such as tremors.
Much of the excitement in this new field of bioelectronics, however, is focused on the vagus nerve, the longest nerve in the body, which starts at the base of the brain and then divides into two branches that run through the neck, chest and into the abdomen, down to the small intestine.
It is described as the communication path of the body – which transmits messages from tissues and organs to the brain and vice versa, controls everything from swallowing to heartbeat and digestion, explaining its appeal as an aid in the treatment of diseases. Vagus nerve stimulation is already being used to reduce the number and severity of seizures in epilepsy when drugs are not working. It is also used for depressions that are resistant to other therapies.
The new approach is revolutionary because it focuses on inflammation (see main story) and can help a wide range of acute and chronic diseases.
“I receive letters and emails from patients and parents of children who suffer every day, but of course we can’t give them any devices yet,” says Dr. Tracey. “I answer a few myself – they bring tears to your eyes. But the question is so overwhelming that we have hired a patient who is now in remission to answer these emails for me. “
That patient was Kelly, who now works as education and outreach director at The Feinstein Institute. “We currently have more than 1,000 patients registered, with the full range of inflammatory diseases waiting anxiously for access to bio-electronic medicine,” she says.
Dr. Tracey says that many diseases with inflammatory components can respond to this treatment. Probably candidates are asthma, diabetes and high blood pressure.
This is not the first time electronic stimulation has been used as a treatment (see box below), but this is the first technique that offers so many potential applications – thanks to Dr. Discover’s discovery. Tracey that stimulation of the nerve inhibits the production of a molecule called tumor necrosis factor, which communicates immune responses to cells.
This molecule is one of the major targets of drugs used to treat inflammatory diseases such as Crohn’s and rheumatoid arthritis.
Electronic stimulation of nerves can have applications that go beyond controlling the inflammatory responses of the body, such as research into treatment for high blood pressure hopes to prove.
An American company, CVRx, has developed a clavicle device 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 ensures that the brain relaxes blood vessels, slows the heart rate and thus lowers blood pressure.
Perhaps not surprisingly, big names are now rushing to invest in bio-electronics, including Google and General Electric, as well as leading US public authorities such as the National Institutes of Health. The British company GlaxoSmithKline also supports more than 30 bio-electronic projects around the world.
In the UK, Qasim Aziz, professor of neurogastroenterology at Queen Mary, University of London, and medical adviser of charity Crohn’s & Colitis UK, is planning a study to investigate the potential of bioelectronics for patients with inflammatory bowel disease.
He told Good Health that Kelly, Crohn’s disease, was part of, although small, “raises the hope that such an intervention can have a promising influence on the management of patients for chronic and often serious conditions such as Crohn’s disease.”
He added:[It’s] an exciting new approach that can benefit many patients. “
Dr. Tracey is hopeful that the use of bioelectronic devices for the treatment of rheumatoid arthritis can be approved by the US Food and Drug Administration “within just three or four years.”
If successful, approval for use in other circumstances may follow.
A spokesperson for the Medicines and Healthcare products Regulatory Agency, responsible for the approval of new medicines in the UK, said it does not approve medical devices itself, but instead supervises ‘notified bodies’ that are authorized to ensure that each new device complies with the requirements of the Medical Device Regulations 2002.
If they do, they earn a CE mark that the device approves for use throughout Europe.
Two years after her procedure, Kelly remains a great advertisement for the effectiveness of bio-electronic medicine. A colonoscopy after the examination showed that 50 percent of her once chronically inflamed colon had healed in less than four months.
“I need to be further examined this summer, but I keep feeling a million dollars,” she says.
She is, understandably, always grateful to Dr. Tracey.
“He and his team have put together the puzzle pieces that will change the course of medicine as we know it,” she says. “I am convinced that this is the new limit.”
Hospital test to see if it can treat heart failure
Five hospitals in the UK, including the world-famous Harefield Hospital, are participating in a study with 480 patients to test the effectiveness of the device in the treatment of heart failure.
Another team, working with SetPoint and led by Professor Peder Olofsson of the renowned Karolinska Institute in Sweden, reported experiments with mice last year that suggested vagus nerve stimulation could help a series of “common and debilitating acute and chronic illnesses,” including septic shock and heart disease. Professor Olofsson told Good Health that his team’s work “focuses on the immune system and inflammation, which play a role in so many aspects of life.”
He adds: “In fact, most diseases have some kind of inflammatory component, from cardiovascular medicine to Crohn’s, psoriasis – even cancer. Some cancers rely on inflammation to thrive.
“So there is a broad strip of medicines that can benefit from these insights.”