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Statistical Approaches in the Development of Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Oleksandr Sverdlov, Yevgen Ryeznik, Sergei Leonov, Valerii Fedorov
An important class of DTx products comes from bioelectronics, which uses medical devices to modulate individual cell behavior for the desired treatment effect. For instance, remote nonpainful electrical stimulation on the upper arm skin can activate inhibitory pain centers and reduce migraine pain (Yarnitsky et al., 2017). A wireless, wearable battery-operated stimulation unit, controlled with a smartphone app has been shown technically reliable, safe, and efficacious in a series of clinical trials of acute migraine, with a potential to be the first line of treatment for some patients (Rapoport et al., 2020). While the active ingredient of non-invasive neuromodulation is different from drug exposure, it purports to provide a direct treatment effect via careful application to the human body.
Bio-Implants Derived from Biocompatible and Biodegradable Biopolymeric Materials
Published in P. Mereena Luke, K. R. Dhanya, Didier Rouxel, Nandakumar Kalarikkal, Sabu Thomas, Advanced Studies in Experimental and Clinical Medicine, 2021
Electrical circuitry is implanted into the nerve cells to activate the parts and structures of the nervous system are called neural implants. Many experiments in the 1960s, material sciences, and the progress in medical and neuroscience lead to advancements in therapies of neurological diseases. This will lead to repair and rehabilitation of lost functions of human systems [80, 81]. Neuromodulation is the process of stimulation of the central nervous system (CNS). These structures which will be modulating the nerve excitability and neurotransmitters release [80]. Patients suffering from Parkinson’s disease (PD) will be cured by suppressing tremor and movement disorders by deep brain stimulation. Similarly, treatment for epilepsy and other psychiatric diseases like depression and obsessive-compulsive disorder are done with the help of vagal nerve stimulation [82, 83]. These treatments are now expanded to psychiatric diseases and many more applications. Some of them are in the development stages in preclinical and clinical trials.
Synapses
Published in Nassir H. Sabah, Neuromuscular Fundamentals, 2020
Neuromodulation is broadly defined as the alteration of neuronal activity through application of a stimulating agent, which could be electrical or chemical. In the present context, the term neuromodulator refers to a chemical agent that affects neurons over a relatively large area of the brain or the spinal cord, mostly through G protein-coupled receptors. Neuromodulators could be neurotransmitters, such as norepinephrine, acetylcholine, dopamine, serotonin, and histamine released by certain groups of neurons but not reabsorbed by the presynaptic neuron – nor broken down. They may be released at nerve endings, as in slow chemical synapses, or they may be carried by the cerebrospinal fluid. Neuromodulators could also be hormones circulating through the blood, such as thyroid hormones, steroid hormones (such as androgen and estrogen), metabolic hormones (such as insulin), stress hormones (such as cortisol), sex hormones (such as testosterone), or neuropeptides such as adenosine or oxytocin.
Anticipating and preventing complications in spinal cord stimulator implantation
Published in Expert Review of Medical Devices, 2023
Steven M. Falowski, Hao Tan, Joseph Parks, Alaa Abd-Elsayed, Ahmed Raslan, Jason Pope
Implantation of these devices is generally considered a relatively minor elective surgical procedure. As with any surgical intervention, SCS implantation carries inherent complication risks with an estimated general incidence of 30–40% [1] [2–4]. In general, SCS complications will fall into one of the following categories: patient-related, component or device-related, surgical technique-related, or biologic complications. Numerous retrospective and prospective studies have been conducted in the past to examine safety and efficacy of neuromodulation devices, and highlight potential complications. The inherent goal is to provide safe, reliable, effective treatment with mitigation of known potential risk of adverse events for patients undergoing these procedures. The authors performed a comprehensive literature review with the objective of discussing the most prevalent complications encountered with SCS implantation in clinical practice. Additionally, the authors offer clinical insight to strategies employed to avoid complications, and to assist clinicians and surgeons in appropriately identifying and treating potential complications when they are encountered.
Deep brain stimulation: new programming algorithms and teleprogramming
Published in Expert Review of Neurotherapeutics, 2023
Renato Puppi Munhoz, Ghadh Albuainain
The areas addressed by these new developments encompass different facets and challenges, including improving flexibility, practical applicability, costs, and improvement in outcomes that have a direct impact on patient’s quality of life, comprising the greatest area of growth within the field of neuromodulation. The potential impact that could be observable in the field over the next few years should take into consideration the need for more individualized therapy, combining neuromodulatory, pharmacological and non-pharmacological approaches. Therefore, future work may consider how novel forms of neuromodulation can be used in combination with other treatment modalities for tailored therapy. Also, according to our current understanding, the decision of when and how to combine these forms of therapy needs to be addressed on a case by case basis, considering also individual patient and clinicians expectations, needs, and preferences.
Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects
Published in Expert Review of Medical Devices, 2022
Sam Tilborghs, Stefan De Wachter
Advancements in research should thrive for restoration of lower urinary tract function and >90% ITT response as definitive endpoints. This could lead to an expansion of different conditions eligible for SNM and potentially even combined treatments. Efficacy rates vary between neuromodulation techniques, with the highest efficacy rates seen for SNM [207]. Currently it is unknown if a combination of (neuromodulation) treatments with different stimulation targets could cause a potential add-on effect. Other options are, for example, percutaneous tibial nerve stimulation (PTNS), however, overall improvements seem to remain modest [208]. While sacral neuromodulation excites a select few pudendal nerve fibers, direct neurostimulation of the pudendal nerve itself may also suppress voiding reflex. Marinkovic et al. stated that pudendal neuromodulation could serve as a welcome addition for failed SNM patients, demonstrating the need for pudendal neuromodulation to be prospectively studied [6].