An innovative alternative for drug-resistant epileptics
In addition to its proven effectiveness and safety, it is inexpensive and easy to use.As a result of a research and development project conducted by the Center for Neurosciences of Cuba (Cneuro), the Institute of Neurology and Neurosurgery, and the Faculty of Mechanical Engineering of the Technological University of Havana (Cujae), the country now has a transcutaneous electrical stimulation equipment of the vagus nerve for the treatment of patients with drug-resistant epilepsy, that is, those who do not respond favorably to the indicated drugs.Named Estep, it is a battery-powered device, customized and easy to use, which obtained its medical registration in 2023, granted by the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed), after the favorable results of the clinical trials, showing a significant reduction in the monthly frequency of epileptic seizures in 83.33% of the patients participating in the study.Doctor in Medical Sciences Mitchell Valdés Sosa, general director of Cneuro, told Granma that epilepsy in Cuba has a prevalence of 280 to 300 cases per 1,000 inhabitants, while worldwide it is estimated that around 30% of people suffering from the disease do not respond to pharmacological treatment.The renowned scientist explained that electrostimulation of the left atrial branch of the vagus nerve is an alternative that has been gaining ground internationally to treat drug-resistant epilepsy, since in general this type of illness requires neurosurgery or neurostimulation, which are invasive and very expensive procedures to apply.According to Valdés Sosa, the device opens promising perspectives in the therapy of the aforementioned ailment, because in addition to its proven effectiveness and safety, it is inexpensive and easy to handle.Therapeutic potentialities have also been identified in migraine, insomnia, depression, learning disorders and recovery after a stroke, said Sosa, who is also a Meritorious Academician of the Cuban Academy of Sciences.As it is for individual use, the patient can apply the therapy at home, after having been previously trained in its use by specialists. The first step is to place the electrodes in the shell of the left ear, and then press the button that sets the device to work.Each electrode is contained in a plastic support, manufactured by 3D printing, which facilitates its placement and automatic adjustment to the morphology of the ear.Once the programmed time for the treatment session has elapsed, the Estep automatically switches off. During the trials, patients and their companions learned to use it in just 15 to 20 minutes of training.ON THE ROAD TO INTRODUCTIONDoctor in Technical Sciences René Iván González Fernández, head of Cneuro's Neurostimulation group and of the Estep project, told this newspaper that it is currently being used by 16 patients, almost all of them participants in the pilot trial conducted between May 2021 and December 2022."Currently, a batch of 140 units is in production at Cneuro's facilities. Part of these devices will be used in a trial with 15 pediatric patients (the previous trial only included adults). Of the remainder, most are to be introduced into the National Health System, while others are to be marketed in different markets."González Fernández stressed that, if the required financing is obtained, other batches will be manufactured, taking into account that demand is high, both in Cuba and abroad."So far, Cuba does not have drug-resistant epilepsy therapy services based on equipment similar to the Estep, hence, depending on the production levels reached in the short and medium terms, we could have this therapeutic tool available in the hospitals that need it."He stressed that, in addition to having full technological sovereignty for its manufacture, the specialists of the Neuroscience Center guarantee the qualified maintenance required by the device during its entire operating cycle. Source: granma.cu,