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Trial record 1 of 1 for:    NCT03169049
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Nerve Conduction Block Using Transcutaneous Electrical Currents

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ClinicalTrials.gov Identifier: NCT03169049
Recruitment Status : Unknown
Verified May 2017 by University of Castilla-La Mancha.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Hospital Nacional de Parapléjicos de Toledo
Information provided by (Responsible Party):
University of Castilla-La Mancha

Tracking Information
First Submitted Date  ICMJE May 25, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date May 30, 2017
Estimated Study Start Date  ICMJE July 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • Baseline Hand Muscle Strength [ Time Frame: Baseline at 0 min ]
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
  • Hand muscle strength after treatment 20 min [ Time Frame: After treatment 20 min ]
    The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
Change from baseline in Muscle strength [ Time Frame: baseline at 0 min, immediately after treatment at 20 min ]
The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nerve Conduction Block Using Transcutaneous Electrical Currents
Official Title  ICMJE Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nerve Block
  • Electric Stimulation
Intervention  ICMJE
  • Device: High-Frequency Stimulation
    high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
  • Device: sham Stimulation
    Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Study Arms  ICMJE
  • Experimental: High-Frequency
    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.
    Intervention: Device: High-Frequency Stimulation
  • Sham Comparator: Sham stimulation
    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: Device: sham Stimulation
Publications * Serrano-Muñoz D, Avendaño-Coy J, Simón-Martínez C, Taylor J, Gómez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03169049
Other Study ID Numbers  ICMJE ddsm10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Castilla-La Mancha
Study Sponsor  ICMJE University of Castilla-La Mancha
Collaborators  ICMJE Hospital Nacional de Parapléjicos de Toledo
Investigators  ICMJE
Principal Investigator: Diego Serrano-Muñoz, MsC Hospital Nacional de Parapléjicos, Toledo
PRS Account University of Castilla-La Mancha
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP