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

Neuromodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884932
• Other study ID #: Neuromodest-pHFAC30
• Status: Completed
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: May 2021
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 16, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrical Stimulation
• Neuromodulation

Intervention

Device:
• 30 kHz stimulation (Myomed 932, Enraf-Nonius)
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)
Sham stimulation will be delivered at a frequency of 30 kHz only during the first 30 seconds.

Locations

Country	Name	City	State
Spain	Castilla-La Mancha University	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	Baseline at 0 minutes
Primary	Pressure Pain Threshold	The PPT will be measured with an algometer and will be expressed in Newtons	Baseline at 0 minutes
Primary	Muscle strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	Baseline at 0 minutes
Primary	Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	During treatment at 15 minutes
Primary	Pressure Pain Threshold	The PPT will be measured with an algometer and will be expressed in Newtons	During treatment at 15 minutes
Primary	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
Primary	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
Primary	Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	Immediately after treatment at 20 minutes
Primary	Pressure Pain Threshold	The PPT will be measured with an algometer and will be expressed in Newtons	Immediately after treatment at 20 minutes
Primary	Muscle strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	Immediately after treatment at 20 minutes
Primary	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
Primary	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
Primary	Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	Immediately after treatment at 30 minutes
Primary	Pressure Pain Threshold	The PPT will be measured with an algometer and will be expressed in Newtons	Immediately after treatment at 30 minutes
Primary	Muscle strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	Immediately after treatment at 30 minutes
Secondary	Baseline nerve temperature	Nerve temperature will be measured using a termodoppler (Celsius degrees)	Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
Secondary	Numerical Discomfort Rate Score	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)	After the intervention at 35 minutes
Secondary	Numerical Pain Rate Score	The NRS consists of a scale from 0 (no pain) to 10 (worst possible pain)	After the intervention at 35 minutes
Secondary	Number of participants with intervention-related adverse effects	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.	After the intervention at 35 minutes
Secondary	Blinding success	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.	After the intervention at 35 minutes