SBIR-STTR Award

The prevalence of obesity is rising to epidemic proportions around the world at an alarming rate. Obesity is a serious medical problem: in the United States, it is estimated that about 300,000 deaths are caused by obesity every year; more than $100 billion is spent each year for the treatment of obesity and its primary co-morbidities. However, currently there is no satisfactory therapy for morbid obesity and there is a great need to explore new therapeutic options. The long-term aim of this project is to develop a safe and effective therapy using intestinal electrical stimulation for the treatment of morbid obesity. This is based on our preliminary data demonstrating that intestinal electrical stimulation inhibits gastric motility, induces vomiting and reduces food intake. The aim of this project is to prove feasibility of intestinal electrical stimulation for the treatment of obesity in dogs. Specific aims are: 1) to study the effect of intestinal electrical stimulation on gastric tone/contractions as well as gastric emptying and to derive the most effective stimulation method that inhibits gastric motility; 2) to investigate the efficacy and safety of intestinal electrical stimulation in reducing food intake; and 3) to study vagally-mediated mechanisms involved with intestinal electrical stimulation. It is anticipated that intestinal electrical stimulation inhibits gastric contractions or induces gastric relaxation, impairs gastric myoelectrical activity and delays gastric emptying, leading to a significant reduction in food intake in a canine model. It is further hypothesized that the inhibitory effects of intestinal electrical stimulation on gastric motility and food intake are mediated via the vagal afferent pathway. Further studies on the long-term effects of intestinal electrical stimulation on weight loss, possible mechanisms involving certain hormones, such as CCK, and the development of an implantable stimulator will be the topics of the Phase II application.

Thesaurus Terms:
biomaterial evaluation, gastrointestinal absorption /transport, gastrointestinal motility /pressure, gastrointestinal stimulator, method development, nonhuman therapy evaluation, obesity implant, nutrient intake activity, stomach emptying dog, medical implant science

Obesity is a serious medical problem: in the United States alone, it causes approximately 300,000 deaths and estimated healthcare costs in the amount of $100 billion per year. However, currently available therapy remains unsatisfactory. In this project, we propose to electrically stimulate the small intestine for the treatment of obesity. The feasibility of intestinal electrical stimulation has been demonstrated in Phase I of this project. The long-term aim is to develop an implantable stimulator for the treatment of patients with obesity using the proposed IES method. It is hypothesized that IES reduces weight by reducing food intake via its inhibitory effects on stomach motor functions and by reducing intestinal absorption via its excitatory effect on intestinal transit of nutrients. The specific aims of this project are to: 1) to test the functionality and reliability of a newly developed implantable stimulator in animals, 2) to optimize the performance of IES with various stimulation parameters in animals, 3) to investigate long-term efficacy and safety in reducing weight in animal models of obesity. A multidisciplinary team has been assembled with extensive knowledge and experience in engineering, physiology and clinical medicine related to device development, the gastrointestinal system, electrical stimulation, and obesity. Physiological experiments are designed to study the feasibility and to optimize the proposed method. A prototype implantable stimulator has been developed. The long-term efficacy and safety of the proposed method will be investigated using the stimulator in a porcine model. It is believed that the technology to be developed in this project will not only lead to a medical breakthrough for obesity but also greatly expand the applications of electrical stimulation to other areas related to the gastrointestinal tract