Clinical perspectives on vagus nerve stimulation: present and future
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Abstract The vagus nerve, the great wanderer, is involved in numerous processes throughout the body and vagus nerve stimulation (VNS) has the potential to modulate many of these functions. This wide-reaching capability has generated much interest across a range of disciplines resulting in several clinical trials and studies into the mechanistic basis of VNS. This review discusses current preclinical and clinical evidence supporting the efficacy of VNS in different diseases and highlights recent advancements. Studies that provide insights into the mechanism of VNS are considered.Keywords:
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The diverse array of end organ innervations of the vagus nerve, coupled with increased basic science evidence, has led to vagus nerve stimulation becoming a management option in a number of clinical disorders. This review discusses methods of electrically stimulating the vagus nerve and its current and potential clinical uses.
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Vagus nerve stimulators currently on the market can treat epilepsy and depression. Recent clinical trials show the potential for vagus nerve stimulation (VNS) to treat epilepsy, autoimmune disease, and traumatic brain injury. As we explore the benefits of VNS, it is expected that more possibilities for a new treatment will emerge in the future. However, existing VNS relies on electrical stimulation, whose limited selectivity (due to its poor spatial resolution) does not allow for any control over which therapeutic effect to induce. We hypothesize that by localizing the stimulation to fascicular level within the vagus nerve with focused ultrasound (US), it is possible to induce selective therapeutic effects with less side effects. A geometrically curve US transducer array that is small enough to wrap around the vagus nerve was fabricated. An experiment was conducted in water, with 48 US elements curved in a 1 mm radius and excited at 15 MHz to test the focusing capabilities of the device. The results show that the geometrical curvature focused the US to an area with a width and height of 110 μm and 550 μm. This will be equivalent to only 2.1% of the cross section of the vagus nerve, showing the potential of focused US to stimulate individual neuronal fibers within the vagus nerve selectively.
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Vagus Nerve Stimulation
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Vagus nerve stimulation (VNS) suppresses inflammation and autoimmune diseases in preclinical and clinical studies. The underlying molecular, neurological, and anatomical mechanisms have been well characterized using acute electrophysiological stimulation of the vagus. However, there are several unanswered mechanistic questions about the effects of chronic VNS, which require solving numerous technical challenges for a long-term interface with the vagus in mice. Here, we describe a scalable model for long-term VNS in mice developed and validated in four research laboratories. We observed significant heart rate responses for at least 4 weeks in 60–90% of animals. Device implantation did not impair vagus-mediated reflexes. VNS using this implant significantly suppressed TNF levels in endotoxemia. Histological examination of implanted nerves revealed fibrotic encapsulation without axonal pathology. This model may be useful to study the physiology of the vagus and provides a tool to systematically investigate long-term VNS as therapy for chronic diseases modeled in mice.
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In a previous paper, the anatomy and physiology of the vagus nerve was discussed in an attempt to explain which vagus nerve fibers and branches are affected by clinically relevant electrical stimulation. This companion paper presents some of vagus nerve stimulation's putative central nervous system mechanisms of action by summarizing known anatomical projections of vagal afferents and their effects on brain biogenic amine pathways and seizure expression.
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The authors studied human vagus nerve electrophysiology intraoperatively on 21 patients (age range: 4 to 31 years) during implantation of a vagus nerve stimulator for seizure control. The study was performed with direct electrical stimulation of the vagus nerve with various stimulation parameters resembling those employed by the Cyberonics NeuroCybernetic Prosthesis System (Houston, TX), which is used clinically for vagus nerve stimulation for treatment of seizures. Recordings were made directly from the rostral end of the vagus nerve. The response of the vagus nerve to various stimulus parameters in patients of different ages was studied. Based on the vagus nerve characteristics, age-related adjustments for stimulus parameters were recommended.
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