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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed polyneuropathy

• Ability to stand and walk unassisted.

• Sensory loss in the feet

Locations
Other Locations
Serbia
Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia
RECRUITING
Belgrade
Contact Information
Primary
Natalija Secerovic, PhD
natalija.katic@pupin.rs
+381631268862
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 20
Treatments
Experimental: Somatosensory feedback
Somatotopic sensory feedback elicited by transcutaneous electrical stimulation (TENS) will be provided to the patients using electrodes integrated into the garment sock. The closed loop system provides stimulation parameter change based on the data recorded with sensorized insoles.
Related Therapeutic Areas
Sponsors
Collaborators: University of Belgrade, Clinical Centre of Serbia, ETH Zurich
Leads: Institute Mihajlo Pupin

This content was sourced from clinicaltrials.gov