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

NCT ID: NCT04884932

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2021-08-16

Brief 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

Electrical Stimulation; Neuromodulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

30 kHz stimulation

Percutaneous application of high frequency electrical current at 30 kHz over the median nerve for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.

Group Type: EXPERIMENTAL

30 kHz stimulation (Myomed 932, Enraf-Nonius)

Intervention Type: DEVICE

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)

Sham stimulation

Electrodes are placed over the median nerve for 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity during the first 30 seconds.

Group Type: EXPERIMENTAL

Sham stimulation (Myomed 932, Enraf-Nonius)

Intervention Type: DEVICE

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

Interventions

30 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)

Intervention Type: DEVICE

Sham stimulation (Myomed 932, Enraf-Nonius)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
• Tolerance to the application of electrotherapy.
• That they have not diagnosed any pathology.
• They do not present a contraindication to puncture and / or the application of electric currents.

Exclusion Criteria

• Neuromuscular disease.
• Epilepsy.
• Trauma, surgery or pain affecting the upper limb
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Avendaño-Coy, PhD

Role: STUDY_DIRECTOR

Castilla-La Mancha University

Locations

Castilla-La Mancha University

Toledo, , Spain

Countries

Spain

References

Alvarez DM, Serrano-Munoz D, Fernandez-Perez JJ, Gomez-Soriano J, Avendano-Coy J. Effect of percutaneous electrical stimulation with high-frequency alternating currents at 30 kHz on the sensory-motor system. Front Neurosci. 2023 Feb 9;17:1048986. doi: 10.3389/fnins.2023.1048986. eCollection 2023.

Reference Type: DERIVED

PMID: 36845426 (View on PubMed)

Other Identifiers

Neuromodest-pHFAC30

Identifier Type: -

Identifier Source: org_study_id