Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosed polyneuropathy - Ability to stand and walk unassisted. - Sensory loss in the feet Who Should NOT Join This Trial: - Open ulcers on the feet - Pregnancy - History of or current psychological diseases that include schizophrenia and major depression - Hypersensitivity to electrical stimulation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosed polyneuropathy * Ability to stand and walk unassisted. * Sensory loss in the feet Exclusion Criteria: * Open ulcers on the feet * Pregnancy * History of or current psychological diseases that include schizophrenia and major depression * Hypersensitivity to electrical stimulation

Treatments Being Tested

DEVICE

Somatosensory feedback

Performing different mobility tasks in 10 separate sessions while the device is providing or not somatotopic sensations through non-invasive electrical stimulation. Benefits connected to the stimulation of sensory nerves will be assessed.

Locations (1)

Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia
Belgrade, Serbia