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
About this trial
This is an interventional treatment trial for Nerve Block focused on measuring nerve conduction block, high frequency stimulation, handgrip
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
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
NCT ID
NCT03169049
First Posted
May 25, 2017
Last Updated
May 26, 2017
Sponsor
University of Castilla-La Mancha
Collaborators
Hospital Nacional de Parapléjicos de Toledo
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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