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Completed

NCT Number: NCT05442021

Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy

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.

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Key information

Conditions

Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APEX Physical Therapy, Cape Coral, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neubie Direct Current Electrical Stimulation Device

Device

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

TENS

Device

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

Primary outcomes

  1. Distal Latency

    Time frame: Pre-intervention

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

  2. Distal Latency

    Time frame: 6 weeks

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

  3. Tibial Motor Nerve Conduction Velocity

    Time frame: Pre-intervention

    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.

  4. Tibial Motor Nerve Conduction Velocity

    Time frame: 6 weeks

    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.

  5. Fibular Motor Nerve Conduction Velocity

    Time frame: 6 weeks

    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. Fibular Motor Nerve Conduction Velocity

    Time frame: Pre-intervention

    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.

  7. Ulnar Motor Nerve Conduction Velocity

    Time frame: Pre-intervention

    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.

  8. Ulnar Motor Nerve Conduction Velocity

    Time frame: 6 weeks

    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.

  9. Sural Sensory Nerve Conduction Velocity

    Time frame: Pre-intervention

    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.

  10. Sural Sensory Nerve Conduction Velocity

    Time frame: 6 weeks

    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.

  11. Superficial Fibular Sensory Nerve Conduction Velocity

    Time frame: 6 weeks

    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.

  12. Superficial Fibular Sensory Nerve Conduction Velocity

    Time frame: Pre-intervention

    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.

  13. Ulnar Sensory Nerve Conduction Velocity

    Time frame: Pre-intervention

    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.

  14. Ulnar Sensory Nerve Conduction Velocity

    Time frame: 6 weeks

    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.

  15. Tibial F-Wave

    Time frame: Pre-intervention

    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.

  16. Tibial F-Wave

    Time frame: 6 weeks

    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.

  17. H-Reflex

    Time frame: 6 weeks

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

  18. H-Reflex

    Time frame: Pre-intervention

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

Sponsors and collaborators

Lead sponsor

NeuFit - Neurological Fitness and Education

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2022
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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