Pathogenesis, diagnosis and clinical management of diabetic sensorimotor peripheral neuropathy.
Gordon Sloan, Dinesh Selvarajah, Solomon Tesfaye
https://pubmed.ncbi.nlm.nih.gov/34050323Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06471517
Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
Led by Institute Mihajlo Pupin · Updated on 2024-06-24
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Institute Mihajlo Pupin
Lead Sponsor
C
Clinical Centre of Serbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a neuroprosthetic device designed to improve problems caused by diabetic neuropathy, a condition resulting from nerve damage often due to diabetes. This condition affects millions worldwide and can lead to sensory loss in the feet, causing difficulties with walking, balance, and increased risk of falls. The study aims to understand if restoring lost sensation with electrical stimulation can reduce these issues and related chronic pain. The study uses a wearable sensory restoration system that provides non-invasive, precise electrical stimulation through electrodes integrated into a sock garment. This system communicates with force-sensitive insoles in the shoes to adjust stimulation in real time, creating a closed-loop feedback system. Participants will perform various mobility tasks during 10 sessions where the device provides somatotopic sensory feedback to affected nerves. Participants will be assessed over about two weeks on factors like the location of sensations evoked by stimulation, stimulation thresholds, and overall safety for up to 1.5 months. Researchers will also measure mobility, balance, neuropathic pain, oxygen consumption during walking, tactile acuity, proprioception, sensitivity, gait performance, foot swelling, and treatment satisfaction. These evaluations help understand the device's impact on sensory and functional outcomes in neuropathy.
CONDITIONS
Brief Title
Neuroprosthetic Device for Improving Issues Caused by Diabetic Neuropathy With Specifically Designed Neural Stimulation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed polyneuropathy
- Ability to stand and walk unassisted
- Sensory loss in the feet
You will not qualify if you...
- Open ulcers on the feet
- Pregnancy
- History of or current psychological diseases including schizophrenia and major depression
- Hypersensitivity to electrical stimulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 weeks
Participants perform different mobility tasks in 10 separate sessions while the device provides somatotopic sensations through non-invasive electrical stimulation. This stage assesses benefits connected to sensory nerve stimulation.
10 visits (in-person)
Trial Site Locations
Total: 1 location
1
Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia
Belgrade, Serbia
Actively Recruiting
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Research Team
N
Natalija Secerovic, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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