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= peripheral Focused Ultrasound Stimulation =

Introduction
Peripheral focused ultrasound stimulation (pFUS) is a non-invasive therapeutic modality, currently in clinical trials, that employs ultrasonic waves to target organ and sub-organ innervation points for neuromodulation.  pFUS has the ability to provide precise intervention without the need for incisions or radiation, making it a potentially safe means of neuromodulation. Research is ongoing into its safety profile. Initial research shows side effects akin to diagnostic ultrasound treatment. Its application includes treating conditions like rheumatoid arthritis, glucose homeostasis. 

Historical Development: Relation to Vagus Nerve Stimulation
The NIH SPARC and DARPA ElectRx programs sought to advance the state of bioelectric medicine. Central to these efforts was investigating stimulation of the vagus nerve for neuromodulation. Electrical stimulation of the vagus nerve could result in imprecise stimulation which activated unintended neural pathways. Exploring the use of ultrasound as an alternative to electricity, not only is it possible to stimulate the vagus nerve with acoustic waves, it is possible to stimulate nerve bodies and terminals distal to the vagus nerve without adjacent pathway activation or invasive procedures, opening up new possibilities for treating epilepsy, depression, and certain inflammatory conditions.

Splenic Ultrasound and the Cholinergic Anti-inflammatory Pathway
pFUS's applications extend to the splenic region, where it can activate the Cholinergic Anti-inflammatory Pathway (CAP). Rheumatoid arthritis, a chronic inflammatory disorder, has been shown to respond to splenic ultrasound by way of CAP modulation. By targeting the spleen with pFUS, it's possible to reduce the production of inflammatory cytokines, providing relief from inflammation and associated symptoms.

Additionally, in conditions like cytokine storms—a severe immune reaction where the body releases excessive inflammatory molecules—controlling the inflammatory response can save healthy tissue from undue harm. pFUS, through its action on the spleen and CAP, offers a potential therapeutic strategy to manage and possibly prevent cytokine storms while still allowing for a non-systemic inflammatory response as well as an adaptive immune response.

Liver Ultrasound and Glucose Homeostasis
The liver plays a pivotal role in maintaining glucose homeostasis. Recent studies have unveiled the potential of pFUS in modulating liver function to maintain glucose balance, especially in conditions like type 2 diabetes. Focused ultrasound can enhance insulin sensitivity and reduce glucose production, offering a novel approach to manage diabetes without the need for medications.

In conditions like endotoxin hyperinsulinemia, where there's an excessive release of insulin due to bacterial endotoxins, pFUS has shown promise in regulating insulin levels, further underscoring its potential in metabolic regulations.

Safety Profile and Current Trials
As with any therapeutic modality, understanding the safety of pFUS is paramount. Rodent Models: Initial trials in rat models have shown that pFUS, when applied correctly, does not cause significant tissue damage or adverse effects. These studies have been foundational in advancing pFUS to larger animals and humans.

Swine Models: Pigs, due to their anatomical and physiological similarities to humans, serve as an excellent model for pFUS trials. Preliminary results indicate a favorable safety profile, paving the way for human trials.

Human Phase 1 Trials: Currently, several phase 1 clinical trials are underway to assess the safety, feasibility, and potential efficacy of pFUS in various conditions. Preliminary results are promising, but comprehensive data is awaited to establish the modality's complete safety profile. 