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

NCT06471517 | Recruiting

• 1 other identifier: DiabeticStim
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy;Peripheral; Neuropathy, Diabetic; Neuropathy, Painful

Outcome Measures

Primary Outcomes (3)

• Location of evoked sensations

  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

  Quantify the lower and higher threshold (charge) stimulus eliciting somatosensory sensation

  through study completion, an average of 2 weeks

• Safety of the participants

  Number of adverse events possibly, probably or causally related to the procedure or device

  up to 1.5 months

Secondary Outcomes (12)

• Impact of providing somatosensory feedback on mobility

  through study completion, an average of 2 weeks

• Impact of providing somatosensory feedback on balance

  through study completion, an average of 2 weeks

• Impact of providing somatosensory feedback on balance

  through study completion, an average of 2 weeks

• Impact of providing sensory feedback on neuropathic pain from pre treatment to post treatment

  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

  up to 1.5 month

Study Arms (1)

Somatosensory feedback

EXPERIMENTAL

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

Interventions

Somatosensory feedback DEVICE

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.

Somatosensory feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed polyneuropathy
• Ability to stand and walk unassisted.
• Sensory loss in the feet

You may not qualify if:

• Open ulcers on the feet
• Pregnancy
• History of or current psychological diseases that include schizophrenia and major depression
• Hypersensitivity to electrical stimulation

Sponsors & Collaborators

• Institute Mihajlo Pupin: lead
• Clinical Centre of Serbia: collaborator
• University of Belgrade: collaborator
• ETH Zurich: collaborator

Study Sites (1)

Clinics for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia

Belgrade, Serbia

RECRUITING

Related Publications (16)

• Sloan G, Selvarajah D, Tesfaye S. Pathogenesis, diagnosis and clinical management of diabetic sensorimotor peripheral neuropathy. Nat Rev Endocrinol. 2021 Jul;17(7):400-420. doi: 10.1038/s41574-021-00496-z. Epub 2021 May 28.

  PMID: 34050323 BACKGROUND

• Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.

  PMID: 23900134 BACKGROUND

• Koke AJ, Schouten JS, Lamerichs-Geelen MJ, Lipsch JS, Waltje EM, van Kleef M, Patijn J. Pain reducing effect of three types of transcutaneous electrical nerve stimulation in patients with chronic pain: a randomized crossover trial. Pain. 2004 Mar;108(1-2):36-42. doi: 10.1016/j.pain.2003.11.013.

  PMID: 15109505 BACKGROUND

• Chee L, Valle G, Marazzi M, Preatoni G, Haufe FL, Xiloyannis M, Riener R, Raspopovic S. Optimally-calibrated non-invasive feedback improves amputees' metabolic consumption, balance and walking confidence. J Neural Eng. 2022 Aug 25;19(4). doi: 10.1088/1741-2552/ac883b.

  PMID: 35944515 BACKGROUND

• Oddsson LIE, Bisson T, Cohen HS, Iloputaife I, Jacobs L, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-The walk2Wellness trial. Front Aging Neurosci. 2022 Sep 20;14:931048. doi: 10.3389/fnagi.2022.931048. eCollection 2022.

  PMID: 36204554 BACKGROUND

• Petrini FM, Bumbasirevic M, Valle G, Ilic V, Mijovic P, Cvancara P, Barberi F, Katic N, Bortolotti D, Andreu D, Lechler K, Lesic A, Mazic S, Mijovic B, Guiraud D, Stieglitz T, Alexandersson A, Micera S, Raspopovic S. Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. Nat Med. 2019 Sep;25(9):1356-1363. doi: 10.1038/s41591-019-0567-3. Epub 2019 Sep 9.

  PMID: 31501600 BACKGROUND

• Petrini FM, Valle G, Bumbasirevic M, Barberi F, Bortolotti D, Cvancara P, Hiairrassary A, Mijovic P, Sverrisson AO, Pedrocchi A, Divoux JL, Popovic I, Lechler K, Mijovic B, Guiraud D, Stieglitz T, Alexandersson A, Micera S, Lesic A, Raspopovic S. Enhancing functional abilities and cognitive integration of the lower limb prosthesis. Sci Transl Med. 2019 Oct 2;11(512):eaav8939. doi: 10.1126/scitranslmed.aav8939.

  PMID: 31578244 BACKGROUND

• Basla C, Chee L, Valle G, Raspopovic S. A non-invasive wearable sensory leg neuroprosthesis: mechanical, electrical and functional validation. J Neural Eng. 2022 Jan 24;19(1). doi: 10.1088/1741-2552/ac43f8.

  PMID: 34915454 BACKGROUND

• Najafi B, Talal TK, Grewal GS, Menzies R, Armstrong DG, Lavery LA. Using Plantar Electrical Stimulation to Improve Postural Balance and Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study. J Diabetes Sci Technol. 2017 Jul;11(4):693-701. doi: 10.1177/1932296817695338. Epub 2017 Feb 1.

  PMID: 28627217 BACKGROUND

• Zeb A, Arsh A, Bahadur S, Ilyas SM. Effectiveness of transcutaneous electrical nerve stimulation in management of neuropathic pain in patients with post traumatic incomplete spinal cord injuries. Pak J Med Sci. 2018 Sep-Oct;34(5):1177-1180. doi: 10.12669/pjms.345.15659.

  PMID: 30344571 BACKGROUND

• Celik EC, Erhan B, Gunduz B, Lakse E. The effect of low-frequency TENS in the treatment of neuropathic pain in patients with spinal cord injury. Spinal Cord. 2013 Apr;51(4):334-7. doi: 10.1038/sc.2012.159. Epub 2013 Jan 8.

  PMID: 23295472 BACKGROUND

• Reeves ND, Orlando G, Brown SJ. Sensory-Motor Mechanisms Increasing Falls Risk in Diabetic Peripheral Neuropathy. Medicina (Kaunas). 2021 May 8;57(5):457. doi: 10.3390/medicina57050457.

  PMID: 34066681 BACKGROUND

• Raspovic A. Gait characteristics of people with diabetes-related peripheral neuropathy, with and without a history of ulceration. Gait Posture. 2013 Sep;38(4):723-8. doi: 10.1016/j.gaitpost.2013.03.009. Epub 2013 Apr 11.

  PMID: 23583607 BACKGROUND

• Pfau DB, Geber C, Birklein F, Treede RD. Quantitative sensory testing of neuropathic pain patients: potential mechanistic and therapeutic implications. Curr Pain Headache Rep. 2012 Jun;16(3):199-206. doi: 10.1007/s11916-012-0261-3.

  PMID: 22535540 BACKGROUND

• Perkins BA, Olaleye D, Zinman B, Bril V. Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care. 2001 Feb;24(2):250-6. doi: 10.2337/diacare.24.2.250.

  PMID: 11213874 BACKGROUND

• Bridenbaugh SA, Kressig RW. Laboratory review: the role of gait analysis in seniors' mobility and fall prevention. Gerontology. 2011;57(3):256-64. doi: 10.1159/000322194. Epub 2010 Oct 27.

  PMID: 20980732 BACKGROUND

MeSH Terms

Conditions

Neuritis; Diabetic Neuropathies; Neuropathy, Painful

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Stanisa Raspopovic, PhD

  Institute Mihajlo Pupin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalija Secerovic, PhD

CONTACT

+381631268862; natalija.katic@pupin.rs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: June 13, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)