HFAC Stimulation (30-50 Kilohertz) in Healthy Volunteers (High Frequency Alternating Current Stimulation)

Summary

High-frequency alternating current (HFAC) stimulation (between 1 kilohertz (kHz) and 100 kHz) on the peripheral nerve has been shown in basic animal research to produce a rapidly reversible nerve block without nerve damage. In human studies, frequencies between 1 kHz and 30 kHz had been applied (both transcutaneously and percutaneously), showing rapidly reversible sensorimotor changes after stimulation without adverse effects. However, the effect of currents with a frequency higher than 30 kHz, which has been shown to be more effective in eliciting nerve block in primates, has not been investigated in humans.

The main objective of this study is to investigate the safety of the intervention and the effect in healthy volunteers of transcutaneous application of alternating currents with frequencies between 30 kHz and 50 kHz on neurophysiological changes in the nerve (nerve conduction velocity and antidromic sensory action potentials (SNAPs), sensory (pain to pressure, epicritic sensitivity and thermal pain to heat) and motor (maximal isometric force) components of the median nerve.

Conditions

• Healthy
• Nerve Block
• Pain

Interventions

OTHER

High-frequency alternating current stimulation

For electrical stimulation in the active groups, unmodulated alternating currents with a symmetrical rectangular waveform of 30 kHz, 40 kHz and 50 kHz will be applied. The current intensity shall be adjusted individually for each participant by increasing the current intensity until the participant reports a "strong but comfortable tingling" sensation just below the excitomotor threshold on the palmar aspect of the hand in the dermatomes innervated by the median nerve. The intensity of the current shall be adjusted every two minutes if the tingling sensation decreases. This protocol has been used in previous studies conducted by our research group

OTHER

Sham current stimulation

Sham electrical stimulation will be performed with the same equipment and electrodes as in the active groups without the participants and the evaluator having a view of the device screen. The intensity of the current will be increased for 30 seconds until the sensory threshold ("strong but comfortable tingling sensation") is exceeded and once the threshold is reached, the intensity will be reduced to 0 mA with 30 seconds ramp down. Participants will not receive electrical current during the rest of the placebo intervention. This protocol was used in other studies with similar interventions to blind participants.

Sponsors & Collaborators

• Ministry of Science and Innovation, Spain

  collaborator OTHER_GOV

• University of Castilla-La Mancha

  lead OTHER

Principal Investigators

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

• Julio Gómez-Soriano, PhD · University of Castilla-La Mancha

• Diego Serrano-Muñoz, PhD · University of Castilla-La Mancha

• Juan José Fernández-Pérez, PhD student · University of Castilla-La Mancha

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-10

Primary Completion

2022-09-20

Completion

2022-12-25

Countries

• Spain

Study Locations