NCT04884932

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

September 5, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 5, 2021

Last Update Submit

September 3, 2021

Conditions

Electrical StimulationNeuromodulation

Keywords

High-frequency alternating currentnerve blocksomatosensory thresholdmotor thresholdpercutaneous electrical stimulation

Outcome Measures

Primary Outcomes (17)

  • Latency of Antidromic median sensory nerve action potential

    The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.

    Baseline at 0 minutes

  • Amplitude of Antidromic median sensory nerve action potential

    The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.

    Baseline at 0 minutes

  • Tactile Threshold

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

    Baseline at 0 minutes

  • Pressure Pain Threshold

    The PPT will be measured with an algometer and will be expressed in Newtons

    Baseline at 0 minutes

  • Muscle strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    Baseline at 0 minutes

  • Tactile Threshold

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

    During treatment at 15 minutes

  • Pressure Pain Threshold

    The PPT will be measured with an algometer and will be expressed in Newtons

    During treatment at 15 minutes

  • Latency Antidromic median sensory nerve action potential

    The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency (NPL) will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.

    Immediately after treatment at 20 minutes

  • Amplitude Antidromic median sensory nerve action potential

    The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.

    Immediately after treatment at 20 minutes

  • Tactile Threshold

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

    Immediately after treatment at 20 minutes

  • Pressure Pain Threshold

    The PPT will be measured with an algometer and will be expressed in Newtons

    Immediately after treatment at 20 minutes

  • Muscle strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    Immediately after treatment at 20 minutes

  • Latency Antidromic median sensory nerve action potential

    The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.

    Immediately after treatment at 30 minutes

  • Amplitude Antidromic median sensory nerve action potential

    The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.

    Immediately after treatment at 30 minutes

  • Tactile Threshold

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

    Immediately after treatment at 30 minutes

  • Pressure Pain Threshold

    The PPT will be measured with an algometer and will be expressed in Newtons

    Immediately after treatment at 30 minutes

  • Muscle strength

    Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

    Immediately after treatment at 30 minutes

Secondary Outcomes (5)

  • Baseline nerve temperature

    Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes

  • Numerical Discomfort Rate Score

    After the intervention at 35 minutes

  • Numerical Pain Rate Score

    After the intervention at 35 minutes

  • Number of participants with intervention-related adverse effects

    After the intervention at 35 minutes

  • Blinding success

    After the intervention at 35 minutes

Study Arms (2)

30 kHz stimulation

EXPERIMENTAL

Percutaneous application of high frequency electrical current at 30 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.

Device: 30 kHz stimulation (Myomed 932, Enraf-Nonius)

Sham stimulation

EXPERIMENTAL

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.

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

Interventions

30 kHz stimulation (Myomed 932, Enraf-Nonius)DEVICE

A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 30 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)

30 kHz stimulation
Sham stimulation (Myomed 932, Enraf-Nonius)DEVICE

Sham stimulation will be delivered at a frequency of 30 kHz only during the first 30 seconds.

Sham stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castilla-La Mancha University

Toledo, 45071, Spain

Location

Related Publications (1)

  • Alvarez DM, Serrano-Munoz D, Fernandez-Perez JJ, Gomez-Soriano J, Avendano-Coy J. Effect of percutaneous electrical stimulation with high-frequency alternating currents at 30 kHz on the sensory-motor system. Front Neurosci. 2023 Feb 9;17:1048986. doi: 10.3389/fnins.2023.1048986. eCollection 2023.

    PMID: 36845426DERIVED

Study Officials

  • Juan Avendaño-Coy, PhD

    Castilla-La Mancha University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 13, 2021

Study Start

May 13, 2021

Primary Completion

July 30, 2021

Study Completion

August 16, 2021

Last Updated

September 5, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)