Neuropathy, Diabetic, Neuropathy, Painful, Neuropathy;Peripheral
Conditions
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.
Interventions
DEVICESomatosensory 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.
Sponsors
Clinical Centre of Serbia
University of Belgrade
ETH Zurich
Institute Mihajlo Pupin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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 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 |
| Treatment Satisfaction Measure | through study completion, an average of 2 weeks | The subject ranks the treatment satisfaction using a Likert-scale. |
| 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 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 open 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 | 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 |
Countries
Serbia
Contacts
Primary ContactNatalija Secerovic, PhD
Outcome results
None listed