Unicamp researchers develop an electrostimulator device to induce the body to produce hormones responsible for the feeling of satiety, promoting control of appetite and eating habits. The goal is to offer people with severe obesity a less invasive alternative to bariatric surgery or gastric balloon surgery. The researchers are now beginning a new phase of studies in which the mechanism of the electrical stimulator will be evaluated.
The technology connects gastric electrical activity with the hormonal responses of the central nervous system. The device has a unit responsible for controlling and generating the signals necessary for sensing and stimulating the gastric wall. It also has one or more electrode leads that are implanted in the anterior gastric wall (proximal to the pylorus) to conduct signals.
The studies began in 2015, when Unicamp was approached by InPulse, a company from Florianópolis, capital of Santa Catarina, which presented a model of electrical stimulator and was looking for partnerships to carry out tests and analyze its viability.
With the partnership signed with the University's Obesity and Comorbidities Research Center (OCRC), in the first round of experiments, a pre-clinical phase carried out between 2015 and 2018, tests were carried out on three groups of pigs for a period of 30 days. The positive response resulted in the obtaining of a patent, which was deposited at the National Institute of Industrial Property with support from the Inova Unicamp Innovation Agency and licensed to InPulse.
Raquel Franco Leal, researcher at the Department of Surgery at the Faculty of Medical Sciences (FCM) at Unicamp and responsible for the team involved in the studies, explains that the animals stopped gaining weight within the growth curve. For the tests, one group of pigs remained with the electrical stimulator turned on, another with the device implanted, but turned off, and the third was kept in place, without any intervention.
The device was implanted through a laparotomy — surgery performed through an abdominal opening. The electrode was placed on the stomach wall and, via a cable, connected to the generating source coupled subaponeurotically, that is, below the muscles.
"This work helped us see the effect of the device. Given the positive results, we moved on to a new phase of the project, which will involve understanding its mechanism”, explains the researcher.
New round of tests aims to confirm how the device acts in the body
With this new round of studies, which will last at least two years, researchers want to confirm whether the electrical stimulator is capable of reducing weight. If this is proven, the team will seek to understand how it acts in the body and whether, in fact, the result is associated with hormonal production.
To do this, tissues will be collected from animals that have the devices implanted for studies of the liver, adipose tissue, peripheral blood, etc. “The pigs in the first phase of testing lost weight. But we need to understand how this is happening and whether there may be other occurrences that interfere with this result”, says Leal.
The tests will be applied to adult pigs, weighing around 50 kilos, unlike the first phase, in which animals weighing 15 kilos and in the growth phase were used. “At first, we thought about developing the device for obese children. In this second round of experiments, we will focus on adult patients, among whom there are more cases of obesity. If there is an effect, we will have a more faithful result than what can happen with a human”, adds the researcher.
Regarding the device, the team has made modifications to increase the durability of the generator's battery and to make its location more accessible and facilitate monitoring. “Despite the improvements we have already made, at this moment, we are focused on evaluating the signal and method. Only after the results, will we develop the equipment to improve the use model and make it commercially viable”, he explains. Gabriel Veloso Paim, technical director at InPulse.
The group will now also have two engineers from Unicamp's Biomedical Engineering Center (CEB), who will provide greater support in any necessary modifications and adjustments to the device.
For Lucas Casagrande Neves, CEO of InPulse, the inclusion of engineers will speed up research. “As they are from engineering, in addition to adding knowledge in the area, the professionals will facilitate process communication and be a link with us.”
Less invasive and innovative alternative for healthcare
The proposal is that the electrical stimulator, in the future, will be implemented through videolaparoscopy, a minimally invasive surgical technique performed using an endocamera in the abdomen. Bariatric surgery, which is one of the main alternatives for patients with severe obesity, although efficient, may not be a definitive solution, since weight regain is quite common.
"People with severe obesity have a very poor prognosis due to associated comorbidities. Therefore, it is important to have alternatives for these patients”, highlights Leal.
For Paim, the partnership between Unicamp and InPulse has been important in addressing a gap between engineering and medicine, which makes it difficult to develop innovative solutions for the healthcare sector. “The desire of doctors to develop equipment like this is old, so much so that there have been scientific articles on the subject since the 1970s. However, it is necessary to have knowledge in engineering for the technology to be developed. This connection between engineering and biomedicine at Unicamp has proven increasingly necessary”, he concludes.
Read the full article published on the Inova Unicamp website.
