This project will deliver a non-invasive, wireless, wearable patch based system for objectively measuring motor activity of the major digestive organs ? stomach, small intestine and colon ? continuously over three days. Motor activity of these organs drive gastrointestinal (GI) motility, which is fundamental to performance of the GI tract, and is therefore involved in numerous disorders and dysfunctions. Some examples are Irritable Bowel Syndrome, Inflammatory Bowel Disease, and gastroparesis in the home use scenario, and post-operative ileus and enteral feeding intolerance in the hospital milieu. The work consists of upgrades and extensions to a prototype system that has been used in multiple clinical trials involving over 200 patients, in both hospital and fully ambulatory settings. Upgrades will address limitations in the prototype performance and readiness for manufacturing under FDA guidelines. The extensions are specific to use in support of SPARC partner teams working on neuro-stimulation research, and will apply to medium size animal models as well as humans.
Specific aims relate to engineering of sub-systems that constitute the full system, the patch mechanical hardware; the internal electronics that acquire raw myoelectric data, digitize it and transmit it to a mobile device; the app that runs on the mobile device that transfers the raw data to a cloud server; the data analysis software that processes individual data sets and extracts motor activity results; and the cohort analysis software that aggregates results from multiple tests and provides tools for studying trends and correlations. Additional aims include early tests of the system on animal models (dogs, mini-pig, pigs) to demonstrate the feasibility of acquiring similar data for use by SPARC partner teams developing and testing their interventions, to assess the efficacy, optimize parameters, and learn about how they affect motor activity of the full GI tract. The early studies will provide feedback to the engineering tasks so that the final system will be effective in animal models and ultimately available for routine use in animals as well as humans.
This project has immediate and direct relevance to public health, as it furthers the development of a diagnostic and monitoring tool for the digestive system. Gastrointestinal (GI) problems affect 15% of the population, the majority of which are problems related to function, yet most current diagnostic modalities measure anatomy, and are expensive and invasive. This system measures function through a wireless and noninvasive, wearable patch coupled to a mobile phone that continuously monitors GI function for several days as the patient goes about their normal daily activities.
