Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
- Conditions
- Neuropathy, DiabeticNeuropathy;PeripheralNeuropathy, Painful
- Interventions
- Device: Somatosensory feedback
- Registration Number
- NCT06471517
- Lead Sponsor
- Institute Mihajlo Pupin
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Diagnosed polyneuropathy
- Ability to stand and walk unassisted.
- Sensory loss in the feet
- Open ulcers on the feet
- Pregnancy
- History of or current psychological diseases that include schizophrenia and major depression
- Hypersensitivity to electrical stimulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Somatosensory feedback 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.
- Primary Outcome Measures
Name Time Method Location of evoked sensations through study completion, an average of 2 weeks Document where on the feet the subject perceives the stimulation locations.
Stimulation threshold range to a variety of stimulus parameters through study completion, an average of 2 weeks Quantify the lower and higher threshold (charge) stimulus eliciting somatosensory sensation
Safety of the participants up to 1.5 months Number of adverse events possibly, probably or causally related to the procedure or device
- Secondary Outcome Measures
Name Time Method Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment up to 1.5 month 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
Impact of providing sensory feedback on volume of oxygen (VO2) consumption (metabolic consumption) during walking through study completion, an average of 2 weeks 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.
Treatment Satisfaction Measure through study completion, an average of 2 weeks The subject ranks the treatment satisfaction using a Likert-scale.
Impact of providing somatosensory feedback on mobility through study completion, an average of 2 weeks 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.
Impact of providing sensory feedback on dual-task gait assessment through study completion, an average of 2 weeks 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.
Impact of providing somatosensory feedback on balance through study completion, an average of 2 weeks 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.
Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment and before and after each session up to 1.5 month 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
Impact of providing sensory feedback on tactile acuity through study completion, an average of 2 weeks 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.
Impact of providing sensory feedback on sensitivity (Quantitative sensory testing) through study completion, an average of 2 weeks Demonstrating if there is a change in quantitative sensory testing score when treatment is provided
Impact of providing superficial stimulation on feet swelling through study completion, an average of 2 weeks Figure-of-Eight method - A tension-controlled measuring tape is wrapped around the ankle and foot for the measurement
Impact of providing sensory feedback on proprioception through study completion, an average of 2 weeks 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.
Trial Locations
- Locations (1)
Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia
🇷🇸Belgrade, Serbia