Clinical Trials Directory

Trials / Completed

CompletedNCT04884932

Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers With 30kHz

Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (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

The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold. However, the 30 kHz frequency has never been applied, and the hypothesis is that it can produce a greater blockage at the sensitive level and be a more comfortable application for the patient. The purpose of the present work is to determine if a greater blockage of the sensory component of the nerve occurs with this frequency and 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
DEVICE30 kHz stimulation (Myomed 932, Enraf-Nonius)A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 30 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 30 kHz only during the first 30 seconds.

Timeline

Start date
2021-05-13
Primary completion
2021-07-30
Completion
2021-08-16
First posted
2021-05-13
Last updated
2021-09-05

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04884932. Inclusion in this directory is not an endorsement.