Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers

Neuromodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346719
• Other study ID #: Neuromodest-pHFAC
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 17, 2020

Study information

• Verified date: November 2020
• 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:

Our previous studies with transcutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold. However, in these studies the intensity needed to reach block threshold is very high. The purpose of the present work 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: 60
• Est. completion date: November 17, 2020
• Est. primary completion date: November 17, 2020
• 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:
• 10 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 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)
• 20 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 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 10 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	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). Negative peak latency (NPL), positive peak latency (PPL), and peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED).	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	Oscillation Frequency of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone. The muscle will be assessed is opponens pollicis muscle	Baseline at 0 minutes
Primary	Stiffness of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle. The muscle will be assessed is opponens pollicis muscle	Baseline at 0 minutes
Primary	Decrement (elasticity) of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction. The muscle will be assessed is opponens pollicis muscle	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	Oscillation Frequency of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone. The muscle will be assessed is opponens pollicis muscle	During treatment at 15 minutes
Primary	Stiffness of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle. The muscle will be assessed is opponens pollicis muscle	During treatment at 15 minutes
Primary	Decrement (elasticity) of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction. The muscle will be assessed is opponens pollicis muscle	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	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). Negative peak latency (NPL), positive peak latency (PPL), and peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED).	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	Oscillation Frequency of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone. The muscle will be assessed is opponens pollicis muscle	Immediately after treatment at 20 minutes
Primary	Stiffness of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle. The muscle will be assessed is opponens pollicis muscle	Immediately after treatment at 20 minutes
Primary	Decrement (elasticity) of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction. The muscle will be assessed is opponens pollicis muscle	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	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). Negative peak latency (NPL), positive peak latency (PPL), and peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED).	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	Oscillation Frequency of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone. The muscle will be assessed is opponens pollicis muscle	Immediately after treatment at 30 minutes
Primary	Stiffness of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle. The muscle will be assessed is opponens pollicis muscle	Immediately after treatment at 30 minutes
Primary	Decrement (elasticity) of tissue assessed by MyotonPro	This outcome measure is obtained by a device named MyotonPro. The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction. The muscle will be assessed is opponens pollicis muscle	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	Baseline flux temperature	Flux will be measured using a termodoppler	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 questionnaire	After the intervention at 35 minutes
Secondary	Blinding success	Blinding of subjects and researchers will be assessed using the James Index	After the intervention at 35 minutes