Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
NCT Number: NCT06471517
Acronym: DiabeticStim
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuropathy;Peripheral|Neuropathy, Diabetic|Neuropathy, Painful
Interventions: DEVICE: Somatosensory feedback
Sponsor: Institute Mihajlo Pupin
Collaborators: Clinical Centre of Serbia|University of Belgrade|ETH Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2025-07-31
Locations: Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Belgrade, Serbia

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.

Primary Outcome Measures: Location of evoked sensations, Document where on the feet the subject perceives the stimulation locations., through study completion, an average of 2 weeks|Stimulation threshold range to a variety of stimulus parameters, Quantify the lower and higher threshold (charge) stimulus eliciting somatosensory sensation, through study completion, an average of 2 weeks|Safety of the participants, Number of adverse events possibly, probably or causally related to the procedure or device, up to 1.5 months
Secondary Outcome Measures: Impact of providing somatosensory feedback on mobility, Demonstration of statistically relevant change of kinematic parameter (m/s) while performing mobility tests (climbing and descending stairs, 10 meter walking test, 6 minutes walking test etc.) with provided sensory feedback compared to the case without the provided sensory feedback., through study completion, an average of 2 weeks|Impact of providing somatosensory feedback on balance, Demonstration of statistically relevant change of score in 4-stage balance test with open eyes with provided sensory feedback compared to the case without the provided sensory feedback., through study completion, an average of 2 weeks|Impact of providing somatosensory feedback on balance, Demonstration of statistically relevant change of score in 4-stage balance test with closed eyes with provided sensory feedback compared to the case without the provided sensory feedback., through study completion, an average of 2 weeks|Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment, Demonstrating the change in level of neuropathic pain using Neuropathic pain symptoms inventory (NPSI) questionnaire. It will be assessed before starting the treatment, every session of the treatment, one day after the last session, one week after the last session, one month after the last session, up to 1.5 month|Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment and before and after each session, Demonstrating the change in level of neuropathic pain using visual analog scale (VAS). It will be assessed every day (overall level of pain), before each session, after each session, up to 1.5 month|Impact of providing sensory feedback on volume of oxygen (VO2) consumption (metabolic consumption) during walking, Demonstration of statistically relevant change of metabolic cost (mLO2/kg/meter) while walking with provided sensory feedback compared to the case without the provided sensory feedback., through study completion, an average of 2 weeks|Impact of providing sensory feedback on tactile acuity, Measured with Two-Point discrimination test. While blindfolded, the patient is repetitively touched with either one or two pins (fixed distance) and asked to tell how many pins he/she feels., through study completion, an average of 2 weeks|Impact of providing sensory feedback on proprioception, Proprioceptive displacement test: patients will be asked to locate the big toe of their feet while not being able to see it. The distance between real and reported placement will be assessed., through study completion, an average of 2 weeks|Impact of providing sensory feedback on sensitivity (Quantitative sensory testing), Demonstrating if there is a change in quantitative sensory testing score when treatment is provided, through study completion, an average of 2 weeks|Impact of providing sensory feedback on dual-task gait assessment, Demonstration of statistically relevant change of dual-task gait assessment score while walking with provided sensory feedback compared to the case without the provided sensory feedback., through study completion, an average of 2 weeks|Impact of providing superficial stimulation on feet swelling, Figure-of-Eight method - A tension-controlled measuring tape is wrapped around the ankle and foot for the measurement, through study completion, an average of 2 weeks|Treatment Satisfaction Measure, The subject ranks the treatment satisfaction using a Likert-scale., through study completion, an average of 2 weeks