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Nerve Conduction Block Using Transcutaneous Electrical Currents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Nerve Block Electric Stimulation Device: High-Frequency Stimulation Device: sham Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: High-Frequency Stimulation
high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

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
Device: sham Stimulation
Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169049


Contacts
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Contact: Diego Serrano-Muñoz, MsC +34 925 24 77 00 ext 47783 dserranomu@externas.sescam.jccm.es
Contact: Julio Gómez-Soriano, PhD +34 925 26 88 00 ext 5845 julio.soriano@uclm.es

Sponsors and Collaborators
University of Castilla-La Mancha
Hospital Nacional de Parapléjicos de Toledo
Investigators
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Principal Investigator: Diego Serrano-Muñoz, MsC Hospital Nacional de Parapléjicos, Toledo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT03169049    
Other Study ID Numbers: ddsm10
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Castilla-La Mancha:
nerve conduction block
high frequency stimulation
handgrip
Additional relevant MeSH terms:
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Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes