Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of neuropathy, participants will enroll in a 6-week treatment regimen at one of 9 Hands On Physical Therapy associated clinic sites listed included in application. The first session will consist of an EMG/NCS evaluation to determine severity of neuropathy and to rule out polyneuropathy, which will serve as baseline (and a within subject control) for the intervention. Participants will then undergo a specialized neuropathy protocol that includes traditional PT therapy for neuropathy, as well as treatment with the Neubie (or traditional e-stim) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense. The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session with the Neubie and 15-min of various physical therapy exercises. 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. At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense. Participants will receive 12 treatments over 6 weeks. EMG/NCS and a neuropathy pain questionnaire will be measured at both the initial evaluation and at the completion of the final session, and will provide both quantitative and qualitative data on the severity of neuropathy symptoms.

Official Title
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Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Peripheral Neuropathy

Conditions
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Neuropathy

Intervention / Treatment
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* Device: Neubie Direct Current Electrical Stimulation Device
* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neubie Direct Current Electrical Stimulation<br>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<br>* Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.<br>|
| Other: Transcutaneous Electrical Nerve Stimulation<br>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<br>* Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, neubie, neuromuscular electrical stimulation