Neuropathy, Painful

The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy. The study will compare three treatment groups: Intraneural Facilitation® (INF®) therapy alone, INF® therapy combined with Neuro vascular index (NVI) food-guided elimination (NVIf), and NVIf alone. The aim is to determine which treatment results in the greatest improvement in neuropathy symptoms, including quality of life, sensory and pain improvements, and functional outcomes.

Neuropathy is a costly and disabling health issue, which consists of a degeneration of the peripheral nerves. Even though the causes may be different, such as diabetes or amputation, the consequences for neuropathic patients are multiple and extremely debilitating. Among the alarming symptoms it implicates, chronic pain and sensory loss are among the most severe ones. Because of the loss of sensations, patients are forced to have an altered gait strategy, an impaired balance and a fivefold increased risk of falling. Furthermore, since they lose sensations and feel numbness in their extremity, they are discouraged in walking, hence leading to a sedentary lifestyle. All of this is worsened by the development of neuropathic pain, which has a high comorbidity with psychological issues, such as depression and anxiety. Today, proper treatments for neuropathic pain that exclude pharmacological solutions are still missing. This is due to the complexity of the neurobiological mechanisms underlying the origin of neuropathy, the multifaceted physical and psychological nature of pain and the lack of reliable biomarkers. The aim of this project is to tackle the major problems connected to neuropathy thanks to non-invasive stimulation of the peripheral nervous system. The system is composed of an insole with pressure sensors that captures in real time the force exerted by the subject on the foot and couples this information with parameters of electrical stimulation. Thanks to optimal electrode placement and intensity modulation, subjects are able to perceive in real-time in a somatotopic manner (i.e., under their foot) how they are walking. The aim now is twofold: first the investigators want to couple this stimulation with Virtual Reality (VR) to develop a neuroadaptive non-invasive brain computer interface (BCI) to treat pain and secondly the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain. Finally, the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain.

Neuropathy refers to a condition that results from damage to the peripheral nerves.The most common cause of it is diabetes mellitus, metabolic disorder that affects more than 422 million individuals worldwide, putting a huge strain on the healthcare system and up to 50% of these individuals will develop neuropathy. Peripheral neuropathy is characterized by sensory nerve abnormalities such as an impaired sense of touch. Sensory loss in feet can lead to functional deficits during gait, low balance, and increased risk of falls and is considered the strongest risk factor for diabetic foot ulceration. Moreover, these patients usually also suffer from neuropathic pain, which is believed to be associated with aberrant sensory input. With this in mind, the study aims to understand the effects of restoring sensation lost to neuropathy using transcutaneous electrical stimulation. Additionally, the investigators aim to understand if electrical stimulation of the damaged nerves can reduce health consequences such as chronic pain. To achieve this, the investigators have developed a wearable sensory restoration system that can restore lost sensation with non-invasive, precisely controlled electrical stimulation through electrodes integrated into the sock garment. A system is composed of a system controller that communicates via Bluetooth with force-sensitive insoles placed in the shoes and neurostimulators directly connected to electrode array socks. Based on the insole recordings the stimulation parameters are defined in real-time, making it a closed-loop system for restoring somatotopic sensory feedback.