Clinical trial NCT06471517: Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
Official title: Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy;Peripheral
Neuropathy, Diabetic
Neuropathy, Painful
Lead sponsor: Institute Mihajlo Pupin
Sponsor class: OTHER
Collaborators: name: Clinical Centre of Serbia
name: University of Belgrade
name: ETH Zurich
First posted: 2024-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Location of evoked sensations
timeFrame: through study completion, an average of 2 weeks
measure: Stimulation threshold range to a variety of stimulus parameters
timeFrame: through study completion, an average of 2 weeks
measure: Safety of the participants
timeFrame: up to 1.5 months
Secondary outcomes:
measure: Impact of providing somatosensory feedback on mobility
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing somatosensory feedback on balance
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing somatosensory feedback on balance
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment
timeFrame: up to 1.5 month
measure: Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment and before and after each session
timeFrame: up to 1.5 month
measure: Impact of providing sensory feedback on volume of oxygen (VO2) consumption (metabolic consumption) during walking
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing sensory feedback on tactile acuity
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing sensory feedback on proprioception
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing sensory feedback on sensitivity (Quantitative sensory testing)
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing sensory feedback on dual-task gait assessment
timeFrame: through study completion, an average of 2 weeks
measure: Impact of providing superficial stimulation on feet swelling
timeFrame: through study completion, an average of 2 weeks
measure: Treatment Satisfaction Measure
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia
Study officials:
affiliation: Institute Mihajlo Pupin
name: Stanisa Raspopovic, PhD
role: PRINCIPAL_INVESTIGATOR
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