Battling Crohn's Disease with Vagus Nerve Stimulation
A woman debilitated from Crohn’s disease tells how vagus nerve stimulation changed her life
Four times a day, 29-year-old Kelly Owens holds a magnet over her chest, activating an implanted deviceÂ that sends gentle electrical pulses up to a large group of nerve fibers inÂ her neck. It makes her voice a little shaky while the stimulation isÂ on. But thatâ€™s nothing compared to the pain sheâ€™s used to enduring.Â
Owens hasÂ Crohnâ€™s disease,Â a condition that causes inflammation in the digestive tract.Â For Owens, the disease has been debilitating, causing pain not only in her gut, but also throughout her body.Â
She is one of 16 Crohnâ€™s sufferers who have enrolled in an experimental trial in Europe where they receive electrical stimulation in an attempt to improve their symptoms. The therapy is part of aÂ burgeoning branch of medicine called electroceuticals, or bioelectronic medicine.Â
The technique harnesses the fact that the human nervous system communicates in the language of electrical impulses. By hacking into that system with artificial impulses, researchers can change, and possibly correct, faulty, disease-causing communication.
Over the last decade, researchers have increasingly looked to electroceuticals to do what drugs and therapyÂ traditionally do:Â improve memory,Â improve organ function,Â correct speech,Â treat vertigo, treatÂ Parkinsonâ€™s disease, alleviateÂ depression,Â and even restore feeling and motion after paralysis.Â
In the ongoing Crohnâ€™sÂ trial, scientists are tapping into the language of theÂ vagus nerve, whichÂ connects the brain to several organ systems, including the gut.Â There are about 100,000 nerve fibers in the vagus nerve at the level of the neck. ByÂ stimulating a subset of those fibers, a signal can be sent down to the spleen. There,Â a series of biological actions leads to a reduction in a particular inflammatory protein, called tumor necrosis factor alpha. When the presence of that protein is reduced, patients tendÂ to get better, the early-stage research shows.
The vagus nerve can be stimulated non-invasively through the skin or with a surgical implant. In the Crohnâ€™sÂ trial in which Owens participated, each subject getsÂ a
Â pulse generator about the size of a pacemakerÂ implanted in his or her chestÂ cavity just under the collarbone. The deviceÂ sends the stimulation through a lead to electrodes that are surgically placed on the vagus nerve in theÂ neck.Â
The study isÂ being conducted byÂ SetPoint Medical, a start-upÂ in Santa Clarita, California. The technique is based on work byÂ Kevin Tracey, president of the Feinstein Institute for Medical Research in Manhasset, New York. HeÂ and his colleagues are credited with discovering the effect of vagus nerve stimulation on inflammatory diseases and the immune system.Â
So far, theÂ trial is going well, according to SetPoint, which this weekÂ released preliminary results.Â Of the 16 people who participated, half of the them experienced clinically meaningful improvements in typical Crohnâ€™s diseaseÂ symptomsâ€”the kind of improvements that will enable them to leave the house, be in less pain, and avoid hospitalizations, according to SetPoint. FourÂ of the subjects experienced remission, meaning they had minimal residual disease.Â
Owens appears to be one of those four in remission. (A SetPoint spokesperson would not confirm this, and saidÂ the companyÂ cannot comment on specific patients). OwensÂ told her story todayÂ atÂ a bioelectronic medicine symposium in Stockholm, Sweden, hosted by Feinstein and the Karolinska Institutet.
In a heartfeltÂ speech, Owens, who grew up inÂ New Jersey, described how herÂ symptomsÂ started at age 13, with inflammatory arthritisÂ in her ankle. Over the next few years, theÂ pain spread to her other ankle, up to her knees and eventually all the way to her arms. She developed digestive problems, heart complications, and deep ulcers on her skinÂ known as pyoderma gangrenosum.
â€œI went very quickly from being an athletic kid to feeling like a 90-year-old woman,â€�Â she said in an interview with Spectrum. â€œIt was hard to relate to other kids who were going through more age-appropriate things.â€�
Her doctors gave her anti-inflammatory drugs, immunosuppressants, steroidsâ€”â€œevery drug under the sun,â€� she saysâ€”but none worked. By her mid 20s,Â she couldnâ€™t walk a couple of blocks without stopping on a bench to rest. Every movement was painful. She had toÂ quit her job as a high school English teacher.Â She developed osteoporosis as a side effect of taking the steroid prednisone
So, when the opportunity arose to enroll in SetPointâ€™sÂ experimental trial, Owens jumped at it.Â She had read about vagus nerve stimulation previously. SetPoint had conducted a small trial in Europe using the same stimulation treatment for people with rheumatoid arthritisâ€”another kind of inflammatory disorderâ€”andÂ reported a successful outcome.Â Owens had a good feeling that the same treatment could work for her disease.Â
SetPointâ€™sÂ Crohnâ€™sÂ study is taking place in five different locations in Europe. Owens was assigned to the Academic Medical Center in Amsterdam. When she arrived, she had to get around the city in a wheelchair.Â
A surgeonÂ implanted her device onÂ June 22, 2017, she says. Stimulation started two weeks later. Two weeks after that â€œI was running from train to train to make my appointments,â€� said Owens in the interview with Spectrum. â€œI remember one time my husband and I were late for an appointmentÂ at the Academic Medical Center, and I ran up two flights of stairs and got to the top and didnâ€™t see my husband anywhere. I looked down to the bottom of the stairs and heâ€™s standing there with his mouth open, shocked at what I had just done.â€�
Now, aÂ year since her surgery, Owens says she runs, does weight training, exercises onÂ the elliptical,Â andÂ has no more Crohnâ€™sÂ symptoms. â€œItâ€™s just gone,â€� she says. â€œI donâ€™t have pain or swelling. Iâ€™m able to eat regular foods. A salad used to destroy my stomach and now I live on salad.â€�Â She still has osteoporosis, but hopes that will improve too with calcium supplements.Â
Owens will continue the stimulation for the foreseeble future. The implant in her chest will likely last about a decade before it needs to be replaced, she says.Â
Owensâ€™ story is just one anecdote to emerge at the beginning of what will surely be a long road of clinical research. Larger, randomized studies, with far more subjects, will be needed before anyone can draw conclusions about the effectiveness of vagus nerve stimulation on inflammatory diseases.Â
There has been at least one other study of vagus nerve stimulation on Crohnâ€™s suffers. Bruno Bonaz at Clinique Universitaire d’HÃ©patoâ€�GastroentÃ©rologie inÂ Grenoble, France, in 2016 reportedÂ positive results in a small trial. Most of the people fromÂ that study are still in disease remission, Bonaz said in an email to Spectrum.Â
And SetPoint in DecemberÂ announcedÂ it would begin a U.S.-based rheumatoid arthritis study, this oneÂ employing a miniaturized, more advanced stimulation device,Â saysÂ
, vice president of product development at SetPoint. For the Crohnâ€™s and previous rheumatoid arthritis trials, the company used an off-the-shelf stimulator developedÂ Cyberonics (now LivaNova) that was designed for the treatment ofÂ epilepsy and depression.Â
The newÂ one, engineered by SetPoint,Â integrates all of the elements of the old stimulatorÂ into one pill-sized implant that gets anchored to the vagus nerve in the neck. It requiresÂ no lead, and no chest cavity implant.
And itâ€™s programmable,Â so turning it on with a magnet wonâ€™t be necessary.Â All patients will have to do is recharge it wirelessly by periodically wearing an external collarÂ around the neck, Calle says.Â
For Owens, now itâ€™s time to pick up where she left off. She wants to go back to work, and looks forward to living like a healthy young woman, she says. The difference between her and most people her age: She already knows what itâ€™s like toÂ feel old.Â Reflecting on the last 15 years, she said: â€œItâ€™s kind of a blessing to have a disease happen at an early age because you get to appreciate things in life that most people donâ€™t appreciate until theyâ€™re much older.Â Itâ€™s a wonderful thing to learn those lessons at a young age.â€�