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Wednesday, April 10, 2019

Researchers Develop A Wearable Twenty-Four Hour GI Tract Monitor

My friend Kendall brought this to my attention. I thought it was an interesting monitoring system, and less invasive than other GI tests. I do not know much about this topic, but I was happy to learn about it as I go. However, there will be a lot of citing, since I have no personal experience with this test. The twenty-four hour GI Tract Monitor articles were released last year, but without Kendal, I would not be aware of this test. So, I want to thank her again.

According to MobiHealthNews,

"UCSD Researchers Develop Wearable, 24-hour GI tract monitor
By Laura LovettMarch 26, 2018

Good news for Winnie-the-Pooh — a new wearable device may be able to track exactly what that rumble in his tummy is.

Now a wearable device, developed by researchers at the GI Innovation Group out of the University of California San Diego, can track electrical activity in the stomach over a 24-hour period. The device works similarly to how an ECG would work for the heart, but instead it monitors the electrical activities of gastrointestinal tract.

In a recent study published by Scientific Reports, researchers found that the device was able collect data comparable to the clinical gold-standard, which is currently an invasive procedure.

'Diseases of the gastrointestinal tract (stomach, intestines, etc) are one of the most common complaints in modern medicine,' Armen Gharibans, the paper's first author and a bioengineering postdoctoral researcher at the University of California San Diego, wrote to MobiHealthNews in an email. 'Oftentimes, symptoms cannot be attributed to a medical condition despite appropriate workup. These disorders fall under the umbrella of functional disorders and make up more than 50 percent of patient referrals to GI specialists. There is an unmet need for new technologies in gastroenterology, especially ones that can monitor the patient outside of the clinic since GI activity and symptoms can vary greatly day to day. We believe the technology we're developing can facilitate better understanding of the pathophysiology of these functional GI disorders and lead to novel and more targeted therapies.'

Right now there are limited resources for monitoring GI conditions, forcing many to go to specialized centers for treatment, according to the study.

The new device is made up of a 3D-printed box that holds the electronics and battery and connects to 10 wearable electrodes. It works as an electrogastrogram (EGG) monitor, and was made from store-bought electrodes that are typically used in ECGs, according to a statement. EGGs often have technological issues including inconsistent results from a single-channel measurement and signal artifacts, which can make it difficult to interpret, according to the study. Researchers aimed to remedy this by using a multi-channel system and artifact removal signal processing methods.

Researchers also developed a smartphone app to where patients can log their activity, bowel movements, sleep, and symptoms. The data from smartphone is then synced with the device data for real-time feedback to the users, according to Gharibans.

In the study, 11 children and one adult tested the device. The children included three males and eight females, aged seven to 17 years with a median BMI of 19. Researchers said that they studied the device on more girls than boys because indigestion is more common among females.

The study participants underwent an antroduodenal manometry where a flexible catheter placed in the participant's nose monitors pressure in the antrum of the stomach. This procedure is commonly used to study the GI tract.

Simultaneously, the participants were fitted with the EGG device, with the electrodes were placed over the stomach. Researchers then recorded the results of both the manometry and the EGG results, and found that their device yielded an increase of 0.56 in the mean correlation coefficient between EGG and the manometry method.

'Our approach is noninvasive, easy to administer, and has promise to widen the scope of populations with GI disorders for which clinicians can screen patients, diagnose disorders, and refine treatments objectively,' the researchers wrote.

The GI Innovation Group is continuing to work on the product but are still in the research phase, which includes collecting more data from patients, understanding limitations, and improving the analysis method, according to Gharibans.

'We would like to eventually bring it to market, so we are actively exploring business opportunities and applying for small business grants to allow us to further develop and miniaturize the technology,' Gharibans wrote.

In the future, Gharibans said the device could monitor a number of GI-related issues, including some very common conditions that impact a large subset of the US population.

'Since our technology is focused on the stomach, the two main GI conditions that this could really help monitor are functional dyspepsia and gastroparesis,' Gharibans wrote. 'Functional dyspepsia (i.e., chronic upset stomach) is reported by up to 20 percent of children and adolescents and is predicted to affect 20 percent to 40 percent of all the US population at least once in their lifetime. Gastroparesis, characterized by delayed gastric emptying in the absence of a mechanical obstruction, affects four percent of the US population, including 70 percent of Parkinson’s patients and 50 percent of diabetes patients. Both of these conditions are under-diagnosed and under-managed'"

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According to Science Daily,

"Researchers have developed a wearable system to monitor stomach activity that performs as well as current state of the art methods but can be used outside of a clinical setting. The system also comes with an app that allows patients to log their meals, sleep and other activities.

Credit: University of California San Diego

A team of researchers has developed a wearable, non-invasive system to monitor electrical activity in the stomach over 24 hours -- essentially an electrocardiogram but for the gastro-intestinal (GI) tract.

Applications include monitoring GI activity for patients outside of a clinical setting, which cuts down costs. Monitoring for longer periods of time also increases the likelihood of capturing abnormal events.

Researchers detail their findings in the March 22 issue of Nature's open access journal Scientific Reports.

The team tested the device, a 3D printed portable box connected to 10 small wearable electrodes, on 11 children and one adult volunteer. They found that data collected with the wearable system were comparable to data collected in the clinic with state-of-the-art methods, which are invasive -- including a catheter inserted through the patient's nose. They also found that the stomach's electrical activity changes not only around meals, but also during sleep, following its own circadian rhythm.

'We think our system will spark a new kind of medicine, where a gastroenterologist can quickly see where and when a part of the GI tract is showing abnormal rhythms and as a result make more accurate, faster and personalized diagnoses,' said Armen Gharibans, the paper's first author and a bioengineering postdoctoral researcher at the University of California San Diego.

Todd Coleman, the paper's corresponding author and a UC San Diego professor of bioengineering, agrees.

'This work opens the door accurately monitoring the dynamic activity of the GI system' he said. 'Until now, it was quite challenging to accurately measure the electrical patterns of stomach activity in a continuous manner, outside of a clinical setting. From now on, we will be able to observe patterns and analyze them in both healthy and unwell people as they go about their daily lives.'

Physicians involved with the study say the device meets an unmet clinical need.

'This will help us determine if the stomach is functioning properly during meals and -- most importantly -- when patients are experiencing symptoms such as nausea and belly pain,' said Dr. David Kunkel, one of the paper's co-authors and a gastroenterologist at UC San Diego Health.

The breakthrough was made possible because engineers and physicians came together to work on the problem, said Benjamin Smarr, one of the paper's co-authors and a chronobiologist at UC Berkeley.

Better algorithms

The researchers' biggest challenge was designing algorithms that recognize and boost the stomach's electrical signals amid noise and artifacts. This is especially difficult to do because the stomach's electrical signals are 10 times weaker than the heart's, making them harder to capture and analyze.

Researchers harnessed the signal processing expertise in Coleman's research group to develop a sophisticated algorithmic pipeline that can clean up the data and separate out abdominal muscle activity (for example when a person walks), heart beats and gastric activity, into different bands of signals that do not overlap. As a result, clinicians can examine each signal individually and compare it to others.

The device and testing

The device itself uses off-the-shelf electrodes used in electrocardiograms. The electronics and battery are encased in a 3D printed box and connected to the electrodes, which fit on a person's abdomen just over the stomach.

The researchers worked with Dr. Hayat Mousa and tested the device on 11 pediatric patients at Rady Children's Hospital in San Diego. These patients had been undergoing an invasive procedure called manometry, one of a couple clinical gold standards for objectively monitoring GI tract activity. The procedure requires using a catheter inserted through the nose to measure pressure at several points inside the stomach. Comparing the two methods showed that data collected by the wearable device was robust and reliable.

'I have been practicing pediatric gastroenterology and taking care of patients for 20 years,' Dr. Mousa said. 'The only method to assess gastrointestinal motility involves placing motility catheters in the GI tracts while kids are sedated or under general anesthesia. It has been a long journey discussing the benefits of doing such an invasive procedure with my patients and their families. My challenge has always been finding a test that offers a non-invasive assessment of the enteric nervous system and its connection with brain function.'

'The technique outlined in this paper is the best way to evaluate children with motility and functional GI disorders,' Dr. Mousa added. 'It provides the information without need for sedation and it offers the flexibility to monitor kids while they continue their daily activities. This procedure allows convenience without compromising accuracy. In addition, it offers the option to assess the brain-gut response to therapeutic interventions including biofeedback and neuromodulation.'

The system is currently paired with a smart phone app that allows patients to log their meals, sleep and other activities. The long-term goal is to design an app that would allow patients and physicians to see the data collected by the device in real time.

'This is analogous to going from switchboard operators straight to smart phones for gastroenterology,' Smarr said.

GI problems, such as delayed emptying of the stomach, are common in patients with diabetes and Parkinson's. This technology could improve the management of these conditions.

Healthy people could also benefit from using the device. For example, competitive athletes and their coaches could monitor GI activity to figure out the best time for meals, especially while traveling across different time zones. Pregnant women suffering from heartburn and other GI problems could use it to monitor the stomach's activity before, during and after meals, as would the elderly. '
'Changes to digestion and gastric health are hallmarks of two understudied processes: aging and pregnancy," UC Berkeley's Smarr said. 'One of our hopes is that this technology will allow us to quantify the changes that happen during these critical periods in life. They affect the vast majority of humanity, and will now be possible to study what's going on, and build predictive, personal medical applications based on getting ahead of bad changes.'

The research was funded by Larry Smarr, UC San Diego Professor in the Department of Computer Science and Engineering and founding director of the California Institute for Telecommunications and Information Technology (or Calit2), through his Harry E. Gruber endowed chair funds.

Story Source:

Materials provided by University of California - San Diego. Note: Content may be edited for style and length.

Journal Reference:

Armen A. Gharibans, Benjamin L. Smarr, David C. Kunkel, Lance J. Kriegsfeld, Hayat M. Mousa, & Todd P. Coleman. Artifact Rejection Methodology Enables Continuous, Noninvasive Measurement of Gastric Myoelectric Activity in Ambulatory Subjects. Scientific Reports, 2018 DOI: 10.1038/s41598-018-23302-9


University of California - San Diego. 'A wearable system to monitor the stomach's activity throughout the day.' ScienceDaily. (accessed April 6, 2019)."

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