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

June 18, 2024 updated by: Institute Mihajlo Pupin

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Somatosensory 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of evoked sensations
Time Frame: through study completion, an average of 2 weeks
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
Time Frame: through study completion, an average of 2 weeks
Quantify the lower and higher threshold (charge) stimulus eliciting somatosensory sensation
through study completion, an average of 2 weeks
Safety of the participants
Time Frame: up to 1.5 months
Number of adverse events possibly, probably or causally related to the procedure or device
up to 1.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of providing somatosensory feedback on mobility
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing somatosensory feedback on balance
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing somatosensory feedback on balance
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment
Time Frame: 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
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
Time Frame: 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
up to 1.5 month
Impact of providing sensory feedback on volume of oxygen (VO2) consumption (metabolic consumption) during walking
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing sensory feedback on tactile acuity
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing sensory feedback on proprioception
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing sensory feedback on sensitivity (Quantitative sensory testing)
Time Frame: through study completion, an average of 2 weeks
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
Time Frame: 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.
through study completion, an average of 2 weeks
Impact of providing superficial stimulation on feet swelling
Time Frame: 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
through study completion, an average of 2 weeks
Treatment Satisfaction Measure
Time Frame: through study completion, an average of 2 weeks
The subject ranks the treatment satisfaction using a Likert-scale.
through study completion, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute Mihajlo Pupin

Collaborators

University of Belgrade
ETH Zurich
Clinical Centre of Serbia

Investigators

  • Principal Investigator: Stanisa Raspopovic, PhD, Institute Mihajlo Pupin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiabeticStim

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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