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

Institute Mihajlo Pupin

Status: Enrolling

Conditions: Neuropathy, Diabetic; Neuropathy;Peripheral; Neuropathy, Painful

Treatments: Device: Somatosensory feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06471517

DiabeticStim

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Somatosensory feedback

Experimental group

Description:

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.

Treatment:

Device: Somatosensory feedback