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Nerve Conduction Block Using Transcutaneous Electrical Currents

Primary Purpose

Nerve Block, Electric Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-Frequency Stimulation
sham Stimulation
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Block focused on measuring nerve conduction block, high frequency stimulation, handgrip

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Neuromuscular disease.
  • Epilepsy.
  • Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
  • Osteosynthesis material in the upper limb.
  • Diabetes.
  • Cancer.
  • Cardiovascular disease.
  • Pacemaker or other implanted electrical device.
  • Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
  • Presence of tattoos or other external agent introduced into the treatment or assessment area.
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    High-Frequency

    Sham stimulation

    Arm Description

    Transcutaneous application of high frequency electrical current over the arm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.

    Electrodes are placed over the arm for a 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel

    Outcomes

    Primary Outcome Measures

    Baseline Hand Muscle Strength
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
    Hand muscle strength after treatment 20 min
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton

    Secondary Outcome Measures

    Change from baseline in Muscle strength
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton

    Full Information

    First Posted
    May 25, 2017
    Last Updated
    May 26, 2017
    Sponsor
    University of Castilla-La Mancha
    Collaborators
    Hospital Nacional de Parapléjicos de Toledo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03169049
    Brief Title
    Nerve Conduction Block Using Transcutaneous Electrical Currents
    Official Title
    Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Castilla-La Mancha
    Collaborators
    Hospital Nacional de Parapléjicos de Toledo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.
    Detailed Description
    In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents). It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason the investigators decided to applied 20KHz to observe the effects on maximal manual force and to compare versus sham stimulation. Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nerve Block, Electric Stimulation
    Keywords
    nerve conduction block, high frequency stimulation, handgrip

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High-Frequency
    Arm Type
    Experimental
    Arm Description
    Transcutaneous application of high frequency electrical current over the arm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.
    Arm Title
    Sham stimulation
    Arm Type
    Sham Comparator
    Arm Description
    Electrodes are placed over the arm for a 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel
    Intervention Type
    Device
    Intervention Name(s)
    High-Frequency Stimulation
    Intervention Description
    high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
    Intervention Type
    Device
    Intervention Name(s)
    sham Stimulation
    Intervention Description
    Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
    Primary Outcome Measure Information:
    Title
    Baseline Hand Muscle Strength
    Description
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
    Time Frame
    Baseline at 0 min
    Title
    Hand muscle strength after treatment 20 min
    Description
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
    Time Frame
    After treatment 20 min
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Muscle strength
    Description
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
    Time Frame
    baseline at 0 min, immediately after treatment at 20 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers Exclusion Criteria: Neuromuscular disease. Epilepsy. Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. Osteosynthesis material in the upper limb. Diabetes. Cancer. Cardiovascular disease. Pacemaker or other implanted electrical device. Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. Presence of tattoos or other external agent introduced into the treatment or assessment area. Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diego Serrano-Muñoz, MsC
    Phone
    +34 925 24 77 00
    Ext
    47783
    Email
    dserranomu@externas.sescam.jccm.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julio Gómez-Soriano, PhD
    Phone
    +34 925 26 88 00
    Ext
    5845
    Email
    julio.soriano@uclm.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diego Serrano-Muñoz, MsC
    Organizational Affiliation
    Hospital Nacional de Parapléjicos, Toledo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30419966
    Citation
    Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. Effect of high-frequency alternating current transcutaneous stimulation over muscle strength: a controlled pilot study. J Neuroeng Rehabil. 2018 Nov 12;15(1):103. doi: 10.1186/s12984-018-0443-2.
    Results Reference
    derived

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    Nerve Conduction Block Using Transcutaneous Electrical Currents

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