Introduction Reimbursement is defined as the “action of repaying a person or institution who has spent or lost money or a sum paid to cover money that has been spent or lost.” 1 1 Taken from the Internet: . In health care, depending on a country’s health care system, a physician is reimbursed for his/her time spent caring for patients, either by receiving a paycheck,…
There are considerable resources available that researchers can draw on to self-educate on the basics of regulatory requirements ( ). These sources are useful for identifying the ways in which regulatory oversight applies, detailing the necessary requirements at each stage. However, many researchers and clinicians do not appreciate that there are steps along the regulatory pathway that can be vague or ambiguous, or that some requirements…
This chapter is devoted to the birth and growth of the neuromodulation industry and the maturation of commercial products that accompanied the industry’s development. We will first take a look at some of the key events that highlighted the early years of the industry. Next, we will examine how the industry matured in the first 16 years of the 21st century. Then we will examine some…
Introduction A start-up company, in any field, starts with an idea, an idea whose innovator thinks will be successful (make money, be needed and wanted) in the market place. For neuromodulation, these ideas usually are birthed by biomedical engineers with either a good eye and ear for business or a businessman with a good eye and ear for biomedical engineering. In any case, as we shall…
Introduction Fatigue and attention disorders are common in modern society and can cause significant difficulties in the lives of those afflicted. Increases in cognitive fatigue are typically characterized by a decline in attention, difficulties concentrating, and increased reaction times ( ). In fact, cognitive impairments caused by just moderate levels of fatigue have been shown to exceed those caused by alcohol intoxication at a blood–alcohol content…
Introduction Noninvasive brain stimulation (NIBS) has been increasingly investigated in the last decades ( ). Two of the most-studied NIBS techniques include transcranial magnetic stimulation (TMS) and transcranial Electrical Stimulation (tES). The concept of NIBS involves the use of electrical or magnetic stimulation to either increase or decrease cortical excitability in a specific brain region ( ). TES uses a weak electrical current to induce changes…
Acknowledgments We would like to acknowledge Jarrett Rushmore, Uri Eden, Christopher Connor, Virgilio Villacorta, and Antoni Valero-Cabre for the work on the initial electrophysiology studies conducted as part of ( ). That material is based in part upon work supported by the Defense Advanced Research Projects Agency (DARPA) under Contract No. W31P4Q-09-C-0117. The views, opinions, and/or findings expressed are those of the author(s) and should not…
Introduction Electrical currents have been used to modulate brain function for several hundreds of years ( ). Rudimentary forms of electrical brain stimulation were introduced by Luigi Rolando, Gustrav Fritsch, and Eduard Hitzing to study the localization of brain function in animals ( ). From then on, the interest in using electrical stimulation to treat neurological and psychiatric disorders increased rapidly, due to its safety profile…
Introduction Since transcranial Direct Current Stimulation (tDCS) is an emerging technology, it is useful to introduce it in the context of other established neuromodulation techniques. Electrotherapy approaches using implanted electrical stimulators, such as Deep Brain Stimulation (DBS) ( ), and Vagus Nerve Stimulation (VNS) ( ), are increasingly being used to treat neurological (e.g., refractory movement disorders) and psychiatric disorders (i.e., severe refractory mood and anxiety…
Acknowledgments Authors are grateful to Melanie French and Jesse Gaboury for their help reviewing the final version of this chapter. Brief Introduction In , Anthony Barker et al. published in Lancet the first report of a new contactless and painless method for stimulating the motor cortex (MC). This novel method used a device to deliver a magnetic pulse over the MC to elicit a recordable electromyographic (EMG)…
Overview Invasive stimulation of the 10th cranial nerve (vagus nerve) has demonstrated a beneficial effect in patients with elevated, body mass indices (BMI) and glucose intolerance/insulin resistance ( ). A review of the scientific literature provides at least two key lines of research that may explain how vagus nerve stimulation (VNS) impacts metabolic processes and control. First, VNS modulates inflammatory signaling pathways in immune cells (e.g.,…
History and Background of Vagus Nerve Stimulation (VNS) Stimulation of the carotid sinus and the vagus nerve (VN) by manual manipulation (deep carotid massage) has a long history of use for the treatment of medical conditions ranging from supraventricular tachycardia (SVT) to status epilepticus. The first use of electrical stimulation of the VN was proposed in by Dr. Corning, who used an electrified, external device to…
Introduction In the late 1920s, Edgar Adrian conducted a series of experiments showing that nerves carry critical information via electrical impulses to and from the brain, which dramatically changed how the human nervous system was viewed ( ). This led to him and Charles Sherrington winning the Nobel Prize in 1932. One particular experiment Adrian conducted had exemplified this idea in a profound way. Adrian had…
Introduction Mammals face threats to life and limb on a daily basis. Survival hinges on multiple strategies, both learned and inborn. For example, zebras display stripes to help blend into the pack and avoid being isolated. Rodents forage for food under cover of darkness to minimize detection by predators. Parents teach their children to look both ways before crossing a busy street. All of these survival…
Introduction Neural control of the heart is dependent upon the dynamic interaction between nested feedback loops that involve peripheral and central aspects of the ANS. The primary structure/function organization of this neural network is summarized in Chapter 104 of this volume and titled, “Autonomic Control of the Heart.” The concept of hierarchical control (see Fig. 129.1 ) is predicated upon the fact that neuronal somata in…
Introduction About 5%–7% of the general population in Western societies are affected by immune-mediated inflammatory diseases ( ) that include, but are not limited to, ankylosing spondylitis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and inflammatory bowel disease (IBD). IBD includes Crohn’s disease (CD) and ulcerative colitis (UC). In the United States, there are more than 1 million people suffering from IBD ( ). The prevalence is increasing.…
Introduction Persistent and nonresolving inflammation has been causally linked to many common disorders. Among these, inflammatory bowel disease (IBD), comprising Crohn’s disease and ulcerative colitis, and rheumatoid arthritis (RA) often affect young and middle-aged adults with severe and life impacting symptoms. IBD and RA affect about 1.4 ( ) and 1.5 ( ) million people in the United States, respectively, with total associated cost estimated between…
Introduction Rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) are chronic autoimmune diseases of complex etiology, affecting approximately 1%–2% of the population. Both diseases cause debilitating symptoms and progressive destruction in the joints and intestinal tract, respectively, severely affecting quality of life. Due to the exacerbating effect of ongoing systemic inflammation, RA patients also carry elevated risk of cardiovascular mortality ( ) while IBD patients have…
Therapeutic Challenges in Inflammatory Disease Inflammation is essential for antimicrobial defense and tissue healing but it must be proportional to the injury or threat and very carefully regulated to restore and maintain homeostasis and health. Excessive and nonresolving inflammation disrupts homeostasis and causes inflammatory diseases. Immune system dysregulation underlies septic shock, rheumatoid arthritis, inflammatory bowel disease, psoriasis, multiple sclerosis, atherosclerosis, certain cancers, and a range of…
History of the Topic History of the Problem Bladder control is profoundly disrupted by spinal cord injury. Bladder and kidney complications are responsible for much morbidity and frequent outpatient and inpatient care, with substantial economic and social costs. Lesions of the cord above the sacral segments that innervate the lower urinary tract interrupt communication between those segments and the brain and pontine micturition center, while leaving…