Clinical trial NCT05230836: HFAC Stimulation (30-50 Kilohertz) in Healthy Volunteers (High Frequency Alternating Current Stimulation)
Official title: Effectiveness and Safety of Electrical Stimulation With Alternating High-frequency Currents (30-50 Kilohertz) on the Sensorimotor System in Healthy Volunteer Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Nerve Block
Pain
Keywords: high-frequency alternating current stimulation
Nerve block
Pain
Strength
Median nerve
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2022-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Four interventions will be performed in randomized order: Group A: 30 kHz HFAC, group B: 40 kHz HFAC, group C: 50 kHz HFAC and group D: simulated electrical stimulation.

kHz (kilohertz)
Primary purpose: TREATMENT

Brief 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.

Detailed description: Electrical stimulation with high-frequency alternating currents (between 1 kHz and 100 kHz) on the peripheral nerve has shown, in basic research with animals, that it produces a rapidly reversible nerve block without causing damage to the nerve. In humans, studies have been carried out with frequencies between 1 kHz and 30 kHz applied both transcutaneously and percutaneously, showing rapidly reversible sensorimotor changes after stimulation and without causing adverse effects. However, the effect of currents with a frequency greater than 30 kHz has not been investigated in humans, which has been shown to be more effective in causing nerve block in primates.

The main objective of this study is to investigate the safety of the intervention and the effect in healthy volunteers of the 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 compound action potentials (PACSA), the sensitive component (pressure pain, epicritic sensitivity and thermal pain to heat) and motor (maximum force) of the median nerve.

A randomized, double-blind, placebo-controlled crossover clinical trial has been designed. The participants will be healthy volunteers between 18 and 40 years old recruited from the students and staff of the Faculty of Physiotherapy and Nursing of the University of Castilla-La Mancha. Four interventions will be performed randomizing the order: Group A: 30 kHz, group B: 40 kHz, group C: 50 kHz and group D: sham electrical stimulation.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer participants.
* Ability to perform all clinical tests and understand the study protocol, as well as obtain informed consent.
* Tolerance to the application of electrotherapy.

Exclusion Criteria:

* Having been treated with an electric current similar to the one applied prior to the intervention.
* Neurological pathology of peripheral or central origin.
* Altered sensitivity in the area of application of the intervention.
* No compromise of continuity.
* History of neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb.
* Diabetes.
* History of cancer.
* Cardiovascular, metabolic or immunological diseases.
* Presence of pacemaker or any other implanted electrical device.
* Taking medication during the study and in the 7 days prior to the study.
* Consumption of narcotic substances during the study and in the 7 days prior to the study.
* Presence of tattoos or any other external agent introduced in the area of treatment and treatment and assessment area (hand).
* Pregnancy.

Primary outcomes:
measure: Pressure pain threshold
timeFrame: Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.
Secondary outcomes:
measure: Compound antidromic sensitive nerve action potentials
timeFrame: Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.
measure: Maximal isometric pinch strength
timeFrame: Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.
measure: Two points discrimination threshold
timeFrame: Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.
measure: Heat pain threshold
timeFrame: Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.
measure: Skin temperature
timeFrame: Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.
measure: Adverse effects and subjective current sensations
timeFrame: Post immediate at 15 minutes and 24 hours after the intervention
measure: Outcome and participant blinding assessment
timeFrame: Post immediate at 15 minutes each intervention.
Other outcomes:
measure: Demographic characteristics
timeFrame: Pre intervention (baseline 0min)
Locations:
city: Toledo
country: Spain
facility: Castilla-La Mancha University
Study officials:
affiliation: University of Castilla-La Mancha
name: Juan Avendaño-Coy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Castilla-La Mancha
name: Julio Gómez-Soriano, PhD
role: STUDY_DIRECTOR
affiliation: University of Castilla-La Mancha
name: Diego Serrano-Muñoz, PhD
role: STUDY_CHAIR
affiliation: University of Castilla-La Mancha
name: Juan José Fernández-Pérez, PhD student
role: STUDY_CHAIR
References:
citation: Megia Garcia A, Serrano-Munoz D, Bravo-Esteban E, Ando Lafuente S, Avendano-Coy J, Gomez-Soriano J. [Analgesic effects of transcutaneous electrical nerve stimulation (TENS) in patients with fibromyalgia: A systematic review]. Aten Primaria. 2019 Aug-Sep;51(7):406-415. doi: 10.1016/j.aprim.2018.03.010. Epub 2018 Jul 17. Spanish.
citation: Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.
citation: Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. Effect of high-frequency alternating current transcutaneous stimulation over muscle strength: a controlled pilot study. J Neuroeng Rehabil. 2018 Nov 12;15(1):103. doi: 10.1186/s12984-018-0443-2.