NCT05230836

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

January 14, 2022

Last Update Submit

May 9, 2022

Conditions

HealthyNerve BlockPain

Keywords

high-frequency alternating current stimulationNerve blockPainStrengthMedian nerve

Outcome Measures

Primary Outcomes (1)

  • Pressure pain threshold

    It will be assessed as an indirect measure of the blockade of the Aδ sensory fibers of the median nerve. Once the applicator is placed perpendicular to the skin, over an uncomfortable spot on the palmar aspect of the non-dominant hand, the pressure shall be increased at a rate of approximately 5 N/s. Three measurements shall be taken with an interval between measurements of 15 seconds, the average of the three measurements shall be taken as the pressure pain threshold.

    Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.

Secondary Outcomes (7)

  • Compound antidromic sensitive nerve action potentials

    Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.

  • Maximal isometric pinch strength

    Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.

  • Two points discrimination threshold

    Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.

  • Heat pain threshold

    Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.

  • Skin temperature

    Baseline, during intervention at 10 minutes, post immediate at 15 minutes and 15 minutes post intervention.

  • +2 more secondary outcomes

Other Outcomes (1)

  • Demographic characteristics

    Pre intervention (baseline 0min)

Study Arms (4)

30 kilohertz

EXPERIMENTAL

Alternating current stimulation at 30 kilohertz via transcutaneous, 15 minutes each intervention with a maximum intensity of 400 milliamperes (mA).

Other: High-frequency alternating current stimulation

40 kilohertz

EXPERIMENTAL

Alternating current stimulation at 40 kilohertz via transcutaneous, 15 minutes each intervention with a maximum intensity of 400 milliamperes (mA).

Other: High-frequency alternating current stimulation

50 kilohertz

EXPERIMENTAL

Alternating current stimulation at 50 kilohertz via transcutaneous, 15 minutes each intervention with a maximum intensity of 400 milliamperes (mA).

Other: High-frequency alternating current stimulation

Sham stimulation

SHAM COMPARATOR

Sham stimulation via transcutaneous, 15 minutes each intervention, following the same procedures as 30, 40 and 50kHz HFAC groups.

Other: Sham current stimulation

Interventions

High-frequency alternating current stimulationOTHER

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

Also known as: Neuromodest® Cibertec-Inc. CHFS 500i
30 kilohertz40 kilohertz50 kilohertz
Sham current stimulationOTHER

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.

Also known as: Neuromodest® Cibertec-Inc. CHFS 500i sham
Sham stimulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castilla-La Mancha University

Toledo, 45071, Spain

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30029964BACKGROUND

  • 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.

    PMID: 32075666BACKGROUND

  • 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.

    PMID: 30419966BACKGROUND

  • 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.

    PMID: 39548560DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan Avendaño-Coy, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

  • Julio Gómez-Soriano, PhD

    University of Castilla-La Mancha

    STUDY DIRECTOR

  • Diego Serrano-Muñoz, PhD

    University of Castilla-La Mancha

    STUDY CHAIR

  • Juan José Fernández-Pérez, PhD student

    University of Castilla-La Mancha

    STUDY CHAIR

Central Study Contacts

Juan Fernández-Pérez, PhD student

CONTACT

+34691336523juanjose.fernandez@uclm.es

Juan Avendaño-Coy, PhD

CONTACT

926051649juan.avendano@uclm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Blinding of participants and evaluator shall be performed using the same equipment, electrodes, cables, and placement for the actual or placebo treatments. In addition, the participants and the evaluator will not have a view of the equipment screen. Blinding of the outcome assessor will be performed using different team members for randomization of the interventions (Investigator 1), intervention (Investigator 2), evaluation (Investigator 3) and statistical analysis (Investigator 4). Randomization will be kept hidden from participants and research team members in sealed envelopes and only the researcher who will deliver the intervention (researcher 2) will know the group assignment. Successful blinding of participants and evaluator will be analyzed.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 9, 2022

Study Start

February 10, 2022

Primary Completion

September 20, 2022

Study Completion

December 25, 2022

Last Updated

May 16, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, figures, images and appendix)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1 month following article publication
Access Criteria
Investigators whose proposed use of the data has been approved by an independent ethical committee identified for this purpose. This data will be shared only for individual participant data meta-analysis. The proposal should be directed to juan.avendano@uclm.es. The investigator will need to sign a data access agreement. Data will be available for 5 years.

Locations

ES(1)