Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04884932
Other study ID # Neuromodest-pHFAC30
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05013840 - Opinions of Healthcare Providers About Neuromodulation
Completed NCT05013827 - Opinions of Company Representatives About Neuromodulation
Recruiting NCT06193278 - Individual Neuromodulation for PDS N/A
Completed NCT04936659 - Effect of Palpatory Neuromodulation of the Trigeminal Nerve for Tenderness in the Posterior Neck Musculature N/A
Recruiting NCT05466110 - Spinal Cord Stimulation Versus Instrumentation for FBSS N/A
Recruiting NCT05681455 - Physiotherapy for Persistent Function by Superficial Neuromodulation N/A
Completed NCT04346719 - Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers N/A
Completed NCT05591807 - Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract
Not yet recruiting NCT06464445 - Optimization of iTBS for Depression N/A
Not yet recruiting NCT05537597 - Repetitive Transcranial Magnetic Stimulation for Musculoskeletal Pain in Patients With Parkinson's Disease N/A
Recruiting NCT06000592 - Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI N/A
Withdrawn NCT03994991 - Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery N/A
Recruiting NCT06213012 - Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury N/A
Completed NCT04662229 - Efficacy of Eco-guided PENS on Handgrip Strength N/A
Recruiting NCT06030973 - Opinions of Healthcare Providers About a European Neuromodulation Register
Recruiting NCT05350150 - Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study N/A
Recruiting NCT06251479 - Study of the Dynamics of Verbal and Non-verbal Interaction in Healthy Subjects, Through the Recording of Body Movements and Non-invasive Neurophysiological Techniques N/A
Completed NCT04749316 - Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls N/A
Completed NCT03883737 - Percutaneous Neuromodulation on the Anterior Pain Knee N/A