Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2020
CompletedNovember 18, 2020
November 1, 2020
6 months
April 2, 2020
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (26)
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
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Baseline at 0 minutes
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
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
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
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
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
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
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
Pressure Pain Threshold
The PPT will be measured with an algometer and will be expressed in Newtons
During treatment at 15 minutes
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
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Immediately after treatment at 20 minutes
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
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
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
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
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
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Immediately after treatment at 30 minutes
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
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
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
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 (6)
Baseline nerve temperature
Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
Baseline flux 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
- +1 more secondary outcomes
Study Arms (3)
10 kHz stimulation
EXPERIMENTALTranscutaneous application of high frequency electrical current at 10 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.
20 kHz stimulation
EXPERIMENTALTranscutaneous application of high frequency electrical current at 20 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.
Sham stimulation
SHAM COMPARATORElectrodes 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.
Interventions
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)
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 will be delivered at a frequency of 10 kHz only during the first 30 seconds.
Eligibility Criteria
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
Study Officials
- STUDY DIRECTOR
Juan Avendaño-Coy, PhD
Castilla-La Mancha University
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
April 2, 2020
First Posted
April 15, 2020
Study Start
June 1, 2020
Primary Completion
November 17, 2020
Study Completion
November 17, 2020
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share