Dual Pulse Electrical Stimulation for Gastroparesis

DESCRIPTION (provided by applicant): Gastroparesis is defined as delayed emptying of solids and is a common disease defined as delayed emptying of the stomach. It is present in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of patients with functional dyspepsia that affects about 10%-25% of the general population. Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of gastroparesis include nausea, vomiting, early satiety and abdominal bloating. Medical treatment for diabetic gastroparesis is very limited in the USA. A medical device (called Enterra Therapy) using gastric electrical stimulation (GES) is approved for the treatment of severe nausea and vomiting in patients with gastroparesis. However, it does not seem to normalize gastric motility or emptying. A novel method of GES is proposed in this application: two-channel synchronized dual pulse GES. In this method, the configuration and waveforms of electrical stimulation are determined based on a number of pathophysiological factors of gastroparesis, including impaired fundic relaxation, visceral hypersensitivity, gastric dysrhythmia, gastric antral hypomotility, and delayed gastric emptying. The electrical stimulus is composed of long pulses (which will normalize dysrhythmia and enhance fundic relaxation) and short pulses (which will relief symptoms and possibly reduce visceral sensention) delivered at the appearance of the physiological gastric electrical waves (synchronized with gastric electrical waves, which is known to enhance gastric contractions and emptying). A multi-disciplinary team is formed including a veteran researcher in gastroparesis, a gastroenterologist, an electrical engineer and others. Experiments are to be performed in an animal model to test the efficacy and efficiency of the proposed novel method of GES in tackling each of the pathogeneses of gastroparesis and to develop an implantable gastric electrical stimulator which can be implemented using a minimally invasive method of laparascopy. Gastroparesis (slow emptying of the stomach after a meal) is common in patients with diabetes and functional dyspepsia but there are few treatment options. This project is proposed to develop a stomach pacemaker which is cable of improving abnormal functions of the stomach related to this refractory disease. A number of innovative ideas are incorporated into the proposed method to tackle abnormalities related to gastroparesis.