The goal of this project is to investigate the safety and efficacy of multi-channel gastric electrical stimulation (MGS) in the treatment of patients with diabetic gastroparesis refractory to standard medical therapy. Previous animal studies have shown that appropriate multi-channel electrical stimulation of the stomach will: a) entrain gastric myoelectrical activity and thus normalize myoelectrical dysrhythmia; b) improve coupling of gastric myoelectrical activity and thus improve gastric peristaltic waves; c) be more efficient than single channel electrical stimulation by requiring substantially lower energy and is therefore more feasible for permanent surgical implantation of a battery powered pacemaker as a future goal. The proposed clinical study will be performed at the University of Kansas Medical Center and has received both FDA IDE and institutional approvals. The primary parameters assessed will be percentage of gastric retention of a solid meal, severity scores of upper gastrointestinal symptoms, quality of life assessment and monitoring of adverse events. It is hypothesized that MGS will result in accelerated gastric emptying of solids and improved symptoms of gastroparesis and quality of life. The success of this project would demonstrate the feasibility of MGS as a therapeutic approach for the treatment of diabetic gastroparesis and would then lead to the next steps of development and test of a permanently implanted device. The MGP-1 Multi-channel Gastric Pacemaker to be used in the proposed clinical study was developed by Virginia Technologies, Inc. and funded through a successful NIH NIDDK SBIR I grant (1 R43 DK58487-01). Development of the MGP-2, and implantable version of the MGP-1, is currently being funded through an NIH NIDDK SBIR II grant (2 R44 DK058487-02). Phase II of this project will investigate the safety and efficacy of the MGP-2 in human subjects.
Thesaurus Terms: biomedical equipment development, electronic stimulator, electrostimulus, implant, paralysis, stomach, stomach motility /pressure, therapy diabetes mellitus, diabetes mellitus therapy, human therapy evaluation, medical complication, stomach emptying clinical research, human subject, patient oriented research
