HFAC Stimulation (30-50 Kilohertz) in Healthy Volunteers (High Frequency Alternating Current Stimulation)
NCT ID: NCT05230836
Last Updated: 2022-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
34 participants
INTERVENTIONAL
2022-02-10
2022-12-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
kHz (kilohertz)
TREATMENT
DOUBLE
Study Groups
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30 kilohertz
Alternating current stimulation at 30 kilohertz via transcutaneous, 15 minutes each intervention with a maximum intensity of 400 milliamperes (mA).
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
40 kilohertz
Alternating current stimulation at 40 kilohertz via transcutaneous, 15 minutes each intervention with a maximum intensity of 400 milliamperes (mA).
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
50 kilohertz
Alternating current stimulation at 50 kilohertz via transcutaneous, 15 minutes each intervention with a maximum intensity of 400 milliamperes (mA).
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
Sham stimulation
Sham stimulation via transcutaneous, 15 minutes each intervention, following the same procedures as 30, 40 and 50kHz HFAC groups.
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Ministry of Science and Innovation, Spain
OTHER_GOV
University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Juan Avendaño-Coy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Castilla-La Mancha
Julio Gómez-Soriano, PhD
Role: STUDY_DIRECTOR
University of Castilla-La Mancha
Diego Serrano-Muñoz, PhD
Role: STUDY_CHAIR
University of Castilla-La Mancha
Juan José Fernández-Pérez, PhD student
Role: STUDY_CHAIR
University of Castilla-La Mancha
Locations
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Castilla-La Mancha University
Toledo, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Fernandez-Perez JJ, Serrano-Munoz D, Gomez-Soriano J, Alvarez DM, Avendano-Coy J. Selective nociceptive modulation using a novel prototype of transcutaneous kilohertz high-frequency alternating current stimulation: a crossover double-blind randomized sham-controlled trial. J Neuroeng Rehabil. 2024 Nov 15;21(1):203. doi: 10.1186/s12984-024-01503-w.
Other Identifiers
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2021-006548-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MCIN/10.13039/501100011033
Identifier Type: OTHER
Identifier Source: secondary_id
neuromodest-gifto
Identifier Type: -
Identifier Source: org_study_id
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