Nerve Conduction Block Using Transcutaneous Electrical Currents

Nerve Block Clinical Trial

Official title:

Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03169049
• Other study ID #: ddsm10
• Status: Not yet recruiting
• Phase: N/A
• First received: May 25, 2017
• Last updated: May 26, 2017
• Start date: July 2017
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: University of Castilla-La Mancha
• Contact: Diego Serrano-Muñoz, MsC
• Phone: +34 925 24 77 00
• Email: dserranomu[@]externas.sescam.jccm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Electric Stimulation
• Heart Block
• Nerve Block

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Nacional de Parapléjicos de Toledo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Hand Muscle Strength	The hand muscle strength will be measured with a dynamometer and will be expressed in Newton	Baseline at 0 min
Primary	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	Change from baseline in Muscle strength	The hand muscle strength will be measured with a dynamometer and will be expressed in Newton	baseline at 0 min, immediately after treatment at 20 min