Clinical Trials Directory

Trials / Completed

CompletedNCT04346719

Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers

Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University of Castilla-La Mancha · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has been used in animal studies to produce a motor nerve block. It has been evidenced that frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in primates, whose nerve thickness is more similar to humans.

Detailed description

Our previous studies with transcutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold. However, in these studies the intensity needed to reach block threshold is very high. The purpose of the present work is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.

Conditions

Interventions

TypeNameDescription
DEVICE10 kHz stimulation (Myomed 932, Enraf-Nonius)A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
DEVICE20 kHz stimulation (Myomed 932, Enraf-Nonius)A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
DEVICESham stimulation (Myomed 932, Enraf-Nonius)Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.

Timeline

Start date
2020-06-01
Primary completion
2020-11-17
Completion
2020-11-17
First posted
2020-04-15
Last updated
2020-11-18

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04346719. Inclusion in this directory is not an endorsement.