Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers

University of Castilla-La Mancha

Status: Completed

Conditions: Electrical Stimulation; Neuromodulation

Treatments: Device: Sham stimulation (Myomed 932, Enraf-Nonius); Device: 10 kHz stimulation (Myomed 932, Enraf-Nonius); Device: 20 kHz stimulation (Myomed 932, Enraf-Nonius)

Study type: Interventional

Funder types: Other

Identifiers

NCT04346719

Neuromodest-pHFAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

10 kHz stimulation

Experimental group

Description:

Transcutaneous application of high frequency electrical current at 10 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.

Treatment:

Device: 10 kHz stimulation (Myomed 932, Enraf-Nonius)

20 kHz stimulation

Experimental group

Description:

Transcutaneous application of high frequency electrical current at 20 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.

Treatment:

Device: 20 kHz stimulation (Myomed 932, Enraf-Nonius)

Sham stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham stimulation (Myomed 932, Enraf-Nonius)