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Completed

NCT Number: NCT04884932

Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers With 30kHz

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.

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Key information

Conditions

Electrical Stimulation Neuromodulation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castilla-La Mancha University

Toledo, 45071, Spain

About this study

The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold.

However, the 30 kHz frequency has never been applied, and the hypothesis is that it can produce a greater blockage at the sensitive level and be a more comfortable application for the patient. The purpose of the present work is to determine if a greater blockage of the sensory component of the nerve occurs with this frequency and is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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)

Sham stimulation (Myomed 932, Enraf-Nonius)

Device

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

Primary outcomes

  1. Latency of Antidromic median sensory nerve action potential

    Time frame: Baseline at 0 minutes

    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.

  2. Amplitude of Antidromic median sensory nerve action potential

    Time frame: Baseline at 0 minutes

    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.

  3. Tactile Threshold

    Time frame: Baseline at 0 minutes

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

  4. Pressure Pain Threshold

    Time frame: Baseline at 0 minutes

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

  5. Muscle strength

    Time frame: Baseline at 0 minutes

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

  6. Tactile Threshold

    Time frame: During treatment at 15 minutes

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

  7. Pressure Pain Threshold

    Time frame: During treatment at 15 minutes

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

  8. Latency Antidromic median sensory nerve action potential

    Time frame: Immediately after treatment at 20 minutes

    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.

  9. Amplitude Antidromic median sensory nerve action potential

    Time frame: Immediately after treatment at 20 minutes

    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.

  10. Tactile Threshold

    Time frame: Immediately after treatment at 20 minutes

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

  11. Pressure Pain Threshold

    Time frame: Immediately after treatment at 20 minutes

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

  12. Muscle strength

    Time frame: Immediately after treatment at 20 minutes

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

  13. Latency Antidromic median sensory nerve action potential

    Time frame: Immediately after treatment at 30 minutes

    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.

  14. Amplitude Antidromic median sensory nerve action potential

    Time frame: Immediately after treatment at 30 minutes

    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.

  15. Tactile Threshold

    Time frame: Immediately after treatment at 30 minutes

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

  16. Pressure Pain Threshold

    Time frame: Immediately after treatment at 30 minutes

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

  17. Muscle strength

    Time frame: Immediately after treatment at 30 minutes

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

Secondary outcomes

  1. Baseline nerve temperature

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

    Nerve temperature will be measured using a termodoppler (Celsius degrees)

  2. Numerical Discomfort Rate Score

    Time frame: After the intervention at 35 minutes

    the possible discomfort caused by the interventions will be assess by a numerical rate score. The NRS consists of a scale from 0 (no discomfort) to 10 (worst possible discomfort)

  3. Numerical Pain Rate Score

    Time frame: After the intervention at 35 minutes

    The NRS consists of a scale from 0 (no pain) to 10 (worst possible pain)

  4. Number of participants with intervention-related adverse effects

    Time frame: After the intervention at 35 minutes

    The possible adverse effects caused by the interventions will be assess by a closed questionnaire, where the presence of any adverse effect would be qualified as 1 point and the negative presence of adverse effect as 0 point.

  5. Blinding success

    Time frame: After the intervention at 35 minutes

    Blinding of subjects and researchers will be assessed using the Bang questionary. It will be the question after the intervention, "What type of treatment do you think you have received?" Will be asked, with 5 items: (1) "I firmly believe that I have received an experimental treatment"; (2) "I slightly believe that I have received an experimental treatment"; (3) "I strongly believe that I have received a placebo"; (4) "I slightly think I have received a placebo"; (5) "Don't know, don't answer.", Index where -1 is blinded and 1 is unblinded.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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