Nerve Conduction Block Using Transcutaneous Electrical Currents

NCT03169049 | Unknown

• 1 other identifier: ddsm10
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nerve Block; Electric Stimulation

Keywords

nerve conduction block; high frequency stimulation; handgrip

Outcome Measures

Primary Outcomes (2)

• Baseline Hand Muscle Strength

  The hand muscle strength will be measured with a dynamometer and will be expressed in Newton

  Baseline at 0 min

• Hand muscle strength after treatment 20 min

  The hand muscle strength will be measured with a dynamometer and will be expressed in Newton

  After treatment 20 min

Secondary Outcomes (1)

• Change from baseline in Muscle strength

  baseline at 0 min, immediately after treatment at 20 min

Study Arms (2)

High-Frequency

EXPERIMENTAL

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

Sham stimulation

SHAM COMPARATOR

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

Interventions

High-Frequency Stimulation DEVICE

high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

High-Frequency

sham Stimulation DEVICE

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

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Related Publications (1)

• 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.

  PMID: 30419966 DERIVED

Study Officials

• Diego Serrano-Muñoz, MsC

  Hospital Nacional de Parapléjicos, Toledo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Serrano-Muñoz, MsC

CONTACT

+34 925 24 77 00; dserranomu@externas.sescam.jccm.es

Julio Gómez-Soriano, PhD

CONTACT

+34 925 26 88 00; julio.soriano@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: July 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05