Rheumatoid arthritis (RA), a disease of the immune system, is characterized by harmful inflammation in the joints. Pharmaceutical agents developed to date for RA, including monoclonal antibodies, are plagued by harmful and sometimes lethal side effects. Investigators at the Feinstein Institute discovered in the late 1990’s that electrically stimulating the vagus nerve could turn off the immune system pathways associated with rheumatoid arthritis, colitis, and other inflammatory diseases. This technology has been licensed to a biotechnology company, SetPoint Medical, and clinical trials of their novel bioelectronic medicine device are underway for rheumatoid arthritis and colitis.
Paralysis affects millions of people worldwide with the two leading causes being stroke and spinal cord injury. Feinstein researchers are currently working to understand how to limit damage and provide a pro-regenerative environment to nerve cells after spinal cord injury. Additional studies are ongoing to identify the molecular factors necessary to successfully recover from central nervous system (CNS) injury or disease.
Bioelectronic devices are also under development to create a neural bypass to circumvent damaged neural pathways resulting from stroke, spinal cord injury, traumatic brain injury, multiple sclerosis (MS), motor neuron disease, and other conditions. It has been previously shown that intracortically-recorded signals can be decoded to extract information related to motion allowing paralyzed humans to control computers and assistive devices through imagined movements. In recent years, advances have been made to link decoded brain signals directly to muscles, restoring movement. Researchers are currently looking at ways to develop technology to address not only paralysis and its comorbidities, but a wide variety of diseases and conditions, leveraging the expanding knowledge within the field of bioelectronic medicine.
Uncontrollable blood loss is a leading cause of death on the battlefield and the operating table alike. Researchers at the Feinstein have developed the neural tourniquet, a bioelectronic medical device that uses electronic nerve stimulation to slow blood loss. They have found that using as little as 60 seconds of electrical stimulation to neural pathways to the spleen is sufficient to prepare the body for clotting in the event of a wound. By priming the body’s coagulation system, it is able to clot 50 percent more rapidly and reduce the volume of blood loss by 50 percent. The neural tourniquet is applicable to a range of life-saving scenarios: to the more than 50 million planned surgeries taking place in America each year; to accident scenes where first responders treat bleeding trauma victims; and on the battlefield treating the blood loss of wounded service men and women. To bring the neural tourniquet to market, the Feinstein has partnered with Battelle, a leading non-profit scientific research and development lab. We anticipate that early models of the device will be available within three to five years.
Sepsis is the body’s overwhelming and life-threatening response to infection which can lead to tissue damage, organ failure, and death. Researchers at the Feinstein Institute have been researching the causes of sepsis, developing methods of preventing sepsis occurrence and investigating the mechanisms underlying the cognitive and physical impairment that occurs in up to 25% of sepsis survivors. Sepsis represents an opportunity where therapies involving the regulation of vagus nerve activity may hold promising results.
Feinstein Institute researchers are making strides in advancing our understanding and treatment of several types of cancer, including breast and ovarian cancers, brain tumors, chronic lymphocytic leukemia, (pre-malignant) respiratory papillomas, osteogenic sarcomas, kidney, and prostate cancers. Studies are in place that focus on the discovery and validation of new biomarkers which may serve as targets for bioelectronic medicine in various cancers. By collaborating with other leaders within bioelectronic medicine, the Feinstein Institute is positioned to advance detection, diagnosis and monitoring of cancer. Our scientists are dedicated to the most vital areas of cancer research – clinical trials, basic research and translational research – in order to better understand cancer, and to find new paths for shaping and delivering the best, most effective cancer treatments. At the Feinstein Institute, the long term goal of our research is to understand how primary cancer cells turn into aggressive metastatic cells. This understanding will blaze the path to discoveries that lead to the development of therapeutic strategies for preventing tumors from spreading.
Colitis (in particular, ulcerative colitis which is limited to the colon) is the inflammation of the inner lining of the colon and can be associated with diarrhea, abdominal pain, bloating, and blood in the stool. In a model of experimental colitis, Feinstein researchers have shown that activation of the vagus nerve reduces these symptoms. Therapies involving the regulation of vagus nerve activity hold promise for the effective treatment of colitis.
Crohn’s disease, a chronic inflammatory condition, belongs to a group of conditions known as inflammatory bowel diseases (IBD). It most commonly affects the end of the small bowel (the ileum) and the beginning of the colon, but it may affect any part of the gastrointestinal (GI) tract, from the mouth to the anus. Dr. Kevin Tracey’s research into bioelectronic medicine is currently being used in clinical trials directed at patients with Crohn’s disease, a condition currently afflicting more than 700,000 Americans. SetPoint Medical, a company Dr. Tracey co-founded, is conducting the trials at five European research centers. During the trials, a device will be implanted to stimulate the vagus nerve in order to activate the body’s natural inflammatory reflex and induce the production of natural anti-inflammatory effects.
According to some 2014 estimates, as many as 387 million people worldwide suffer from diabetes, putting the disease’s economic cost at $612 billion. While there are currently no known cures for either variety of Diabetes, research suggests that a small bioelectronics device, implanted on the vagus nerve, may be able to regulate the production of and cellular response to insulin.
Lupus is an autoimmune disease that causes the immune system to lose the ability to differentiate between foreign agents and healthy tissue. It becomes hyperactive and attacks healthy tissue, causing inflammation, swelling, and damage to joints, skin, and internal organs. Feinstein Institute researchers are studying a type of lupus called systemic lupus erythematosus, or SLE, a severe form of lupus that can affect any of the body’s organs. Ongoing studies include the investigation of auto-antibody-mediated brain damage, and the collection of genetic information to identify individuals who are at risk for developing autoimmune disease. Feinstein researchers are developing new therapies for lupus and testing promising new treatments in several clinical trials.
Obesity and Metabolic Syndrome
Metabolic syndrome consists of a group of risk factors (increased blood pressure, a high blood sugar level, excess body fat around the waist and abnormal cholesterol levels) that increase the risk of heart disease. Chronic inflammation, as a result of immune and metabolic dysregulation, is observed in patients with obesity and metabolic syndrome. Feinstein Institute researchers have shown that dysregulation of vagus nerve-mediated anti-inflammatory signaling might contribute to the pathogenesis of obesity and its related comorbidities.