Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy

NCT05442021 | Completed FDA Device

• 1 other identifier: Pro00063515
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 11

Brief Summary

This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating peripheral neuropathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about their impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit, in clinical physical therapy treatment of neuropathy. Outcomes measured will include three methods of two-point discrimination, vibration sense, pain, and score on the modified Toronto Clinical Neuropathy scale.

Conditions

Neuropathy

Keywords

electrical stimulation; neubie; neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (18)

• Distal Latency

  The time in milliseconds that it takes the impulse to travel from the stimulation point at the wrist to the recording electrode.

  Pre-intervention

• Distal Latency

  The time in milliseconds that it takes the impulse to travel from the stimulation point at the wrist to the recording electrode.

  6 weeks

• Tibial Motor Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial Motor Nerve.

  Pre-intervention

• Tibial Motor Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial Motor Nerve.

  6 weeks

• Fibular Motor Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Fibular Motor Nerve.

  6 weeks

• Fibular Motor Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Fibular Motor Nerve.

  Pre-intervention

• Ulnar Motor Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Motor Nerve.

  Pre-intervention

• Ulnar Motor Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Motor Nerve.

  6 weeks

• Sural Sensory Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Sural Sensory Nerve.

  Pre-intervention

• Sural Sensory Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Sural Sensory Nerve.

  6 weeks

• Superficial Fibular Sensory Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Superficial Fibular Sensory Nerve.

  6 weeks

• Superficial Fibular Sensory Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Superficial Fibular Sensory Nerve.

  Pre-intervention

• Ulnar Sensory Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Sensory Nerve.

  Pre-intervention

• Ulnar Sensory Nerve Conduction Velocity

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Sensory Nerve.

  6 weeks

• Tibial F-Wave

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial F-Wave.

  Pre-intervention

• Tibial F-Wave

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial F-Wave.

  6 weeks

• H-Reflex

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.

  6 weeks

• H-Reflex

  Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.

  Pre-intervention

Study Arms (2)

Neubie Direct Current Electrical Stimulation

EXPERIMENTAL

The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session using the Neubie and 15-min of various physical therapy exercises.

Device: Neubie Direct Current Electrical Stimulation Device

Transcutaneous Electrical Nerve Stimulation

OTHER

The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min footbath with TENS and 15-min of various physical therapy exercises.

Device: TENS

Interventions

Neubie Direct Current Electrical Stimulation Device DEVICE

Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.

Neubie Direct Current Electrical Stimulation

TENS DEVICE

Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.

Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

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

You may qualify if:

• Must have a minimum score of 1 on the modified Toronto Clinical Neuropathy Score
• Must be able to attend weekly sessions for the 6 week period of the study (no extended travel)
• Must be at least 18 years old.

You may not qualify if:

• Currently pregnant
• Cardiac pacemaker
• Active or recent cancer in the lower limbs
• Active or recent blood clots in the lower limbs
• History of epilepsy
• No open wounds

Sponsors & Collaborators

• NeuFit - Neurological Fitness and Education: lead

Study Sites (11)

APEX Physical Therapy

Cape Coral, Florida, 33991, United States

Location

Catalyst Physical Therapy

Clearwater, Florida, 33756, United States

Location

APEX Physical Therapy

Fort Myers, Florida, 33908, United States

Location

Diagnostic Solutions

Springfield, Kentucky, 40069, United States

Location

Hands-On Physical Therapy

Astoria, New York, 11106, United States

Location

Hands-On Physical Therapy of Queens Village

Queens Village, New York, 11428, United States

Location

Panetta Physical Therapy & Diagnostics

Ronkonkoma, New York, 11779, United States

Location

Courcier Physical Therapy

Edmond, Oklahoma, 73013, United States

Location

Spine & Rehab Specialists

El Paso, Texas, 79936, United States

Location

Active Fitness Physical Therapy

Oak Hill, West Virginia, 25901, United States

Location

Active Fitness Physical Therapy

Victor, West Virginia, 25938, United States

Location

Related Publications (19)

• Snyder MJ, Gibbs LM, Lindsay TJ. Treating Painful Diabetic Peripheral Neuropathy: An Update. Am Fam Physician. 2016 Aug 1;94(3):227-34.

  PMID: 27479625 BACKGROUND

• Rogers LC, Andros G, Armstrong DG. Update from the Diabetic Foot Global Conference (DFCon) 2007. Int Wound J. 2007 Dec;4(4):295-7. doi: 10.1111/j.1742-481X.2007.00377.x. No abstract available.

  PMID: 18154623 BACKGROUND

• Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510.

  PMID: 24124947 BACKGROUND

• Ziegler D. Treatment of diabetic polyneuropathy: Update 2006. Ann N Y Acad Sci. 2006 Nov;1084:250-66. doi: 10.1196/annals.1372.008.

  PMID: 17151306 BACKGROUND

• Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

  PMID: 14622708 BACKGROUND

• Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3.

  PMID: 9798171 BACKGROUND

• Gilcreast DM, Stotts NA, Froelicher ES, Baker LL, Moss KM. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998 Sep-Oct;6(5):434-41. doi: 10.1046/j.1524-475x.1998.60505.x.

  PMID: 9844163 BACKGROUND

• da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.

  PMID: 25665520 BACKGROUND

• Ordog GJ. Transcutaneous electrical nerve stimulation versus oral analgesic: a randomized double-blind controlled study in acute traumatic pain. Am J Emerg Med. 1987 Jan;5(1):6-10. doi: 10.1016/0735-6757(87)90281-6.

  PMID: 3545246 BACKGROUND

• Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci. 2004 Jan 26;117(Pt 3):397-405. doi: 10.1242/jcs.00868. Epub 2003 Dec 16.

  PMID: 14679307 BACKGROUND

• Kanno S, Oda N, Abe M, Saito S, Hori K, Handa Y, Tabayashi K, Sato Y. Establishment of a simple and practical procedure applicable to therapeutic angiogenesis. Circulation. 1999 May 25;99(20):2682-7. doi: 10.1161/01.cir.99.20.2682.

  PMID: 10338463 BACKGROUND

• Reichstein L, Labrenz S, Ziegler D, Martin S. Effective treatment of symptomatic diabetic polyneuropathy by high-frequency external muscle stimulation. Diabetologia. 2005 May;48(5):824-8. doi: 10.1007/s00125-005-1728-0. Epub 2005 Apr 14.

  PMID: 15830180 BACKGROUND

• DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.

  PMID: 19007541 BACKGROUND

• Doucet BM, Griffin L. High-versus low-frequency stimulation effects on fine motor control in chronic hemiplegia: a pilot study. Top Stroke Rehabil. 2013 Jul-Aug;20(4):299-307. doi: 10.1310/tsr2004-299.

  PMID: 23893829 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

• Chandrasekaran S, Davis J, Bersch I, Goldberg G, Gorgey AS. Electrical stimulation and denervated muscles after spinal cord injury. Neural Regen Res. 2020 Aug;15(8):1397-1407. doi: 10.4103/1673-5374.274326.

  PMID: 31997798 BACKGROUND

• Zehr EP, Collins DF, Chua R. Human interlimb reflexes evoked by electrical stimulation of cutaneous nerves innervating the hand and foot. Exp Brain Res. 2001 Oct;140(4):495-504. doi: 10.1007/s002210100857.

  PMID: 11685403 BACKGROUND

• Yang, Z. et al. Scoring systems to screen for diabetic peripheral neuropathy. (Cochrane Database Syst Rev. 2018 Jul 30;2018(7):CD010974. doi: 10.1002/14651858.CD010974.pub2. eCollection 2018 Jul.).

  RESULT

• Kostopoulos D, Rizopoulos K, McGilvrey J, Hauskey J, Courcier J, Connor-Israel K, Koster H, von Leden R. An Open-Label Comparative Study of the Impact of Two Types of Electrical Stimulation (Direct Current Neuromuscular Electrical Stimulation and Transcutaneous Electrical Stimulation) on Physical Therapy Treatment of Diabetic Peripheral Neuropathy. J Diabetes Res. 2025 Feb 4;2025:9970124. doi: 10.1155/jdr/9970124. eCollection 2025.

  PMID: 39949402 DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ramona von Leden, PhD

  NeuFit - Neurological Fitness and Education

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by clinicians at Hands on Diagnostics locations. Assessors will be blinded to which intervention participant has received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study will be divided into two randomly assigned groups - control and experimental. Control group will receive traditional e-stim treatment with TENS plus physical therapy. Experimental group will receive direct current e-stim treatment with the Neubie device plus physical therapy.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: August 1, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)