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Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers

NCT04346719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-18

No results posted yet for this study

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.

Conditions

  • Electrical Stimulation
  • Neuromodulation

Interventions

DEVICE

10 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)

DEVICE

20 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)

DEVICE

Sham stimulation (Myomed 932, Enraf-Nonius)

Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.

Sponsors & Collaborators

  • University of Castilla-La Mancha

    lead OTHER

Principal Investigators

  • Juan Avendaño-Coy, PhD · Castilla-La Mancha University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-11-17
Completion
2020-11-17

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346719 on ClinicalTrials.gov