Electrical StimulationNCT04884932
Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers With 30kHz
A study testing 30 kHz stimulation (Myomed 932, Enraf-Nonius) in people with Electrical Stimulation and Neuromodulation, run by University of Castilla-La Mancha at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Stimulation, Neuromodulation
- What is being tested?
- 30 kHz stimulation (Myomed 932, Enraf-Nonius)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2021to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz
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.
Read the detailed 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.
- Conditions
- Electrical Stimulation, Neuromodulation
- Being tested
- 30 kHz stimulation (Myomed 932, Enraf-Nonius), Sham stimulation (Myomed 932, Enraf-Nonius)
- Keywords
- High-frequency alternating current, nerve block, somatosensory threshold, motor threshold, percutaneous electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 30 kHz stimulation | Experimental | Percutaneous application of high frequency electrical current at 30 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. Receives: Device: 30 kHz stimulation (Myomed 932, Enraf-Nonius) |
| Sham stimulation | Experimental | Electrodes 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. Receives: Device: Sham stimulation (Myomed 932, Enraf-Nonius) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline at 0 minutes
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.
Measured: Baseline at 0 minutes
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: Baseline at 0 minutes
Pressure Pain Threshold
The PPT will be measured with an algometer and will be expressed in Newtons
Measured: Baseline at 0 minutes
Muscle strength
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Measured: Baseline at 0 minutes
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: During treatment at 15 minutes
Pressure Pain Threshold
The PPT will be measured with an algometer and will be expressed in Newtons
Measured: During treatment at 15 minutes
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.
Measured: Immediately after treatment at 20 minutes
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.
Measured: Immediately after treatment at 20 minutes
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: Immediately after treatment at 20 minutes
Pressure Pain Threshold
The PPT will be measured with an algometer and will be expressed in Newtons
Measured: Immediately after treatment at 20 minutes
Muscle strength
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Measured: Immediately after treatment at 20 minutes
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.
Measured: Immediately after treatment at 30 minutes
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.
Measured: Immediately after treatment at 30 minutes
Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Measured: Immediately after treatment at 30 minutes
Pressure Pain Threshold
The PPT will be measured with an algometer and will be expressed in Newtons
Measured: Immediately after treatment at 30 minutes
Muscle strength
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
Measured: Immediately after treatment at 30 minutes
Secondary outcomes (5)
Baseline nerve temperature
Nerve temperature will be measured using a termodoppler (Celsius degrees)
Measured: Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
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)
Measured: After the intervention at 35 minutes
Numerical Pain Rate Score
The NRS consists of a scale from 0 (no pain) to 10 (worst possible pain)
Measured: After the intervention at 35 minutes
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.
Measured: After the intervention at 35 minutes
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.
Measured: After the intervention at 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start13 May 2021
- Primary completion30 Jul 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrical StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño-Coy, PhD, Study director, Castilla-La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884932
- Sponsor's protocol ID
- Neuromodest-pHFAC30
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez DM, Serrano-Munoz D, Fernandez-Perez JJ, Gomez-Soriano J, Avendano-Coy J. Effect of percutaneous electrical stimulation with high-frequency alternating currents at 30 kHz on the sensory-motor system. Front Neurosci. 2023 Feb 9;17:1048986. doi: 10.3389/fnins.2023.1048986. eCollection 2023.
PubMed 36845426
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz
- ClinicalTrials.gov ID
- NCT04884932
- Acronym / sponsor ID
- Neuromodest-pHFAC30
- Conditions
- Electrical Stimulation, Neuromodulation
- Keywords
- High-frequency alternating current, nerve block, somatosensory threshold, motor threshold, percutaneous electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 kHz stimulation | Experimental | Device: 30 kHz stimulation (Myomed 932, Enraf-Nonius)Percutaneous application of high frequency electrical current at 30 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 | Experimental | Device: Sham stimulation (Myomed 932, Enraf-Nonius)Electrodes 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb
- Osteosynthesis material in the upper limb.
- Diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | 30 kHz stimulation |
| Sham stimulation (Myomed 932, Enraf-Nonius)Sham stimulation will be delivered at a frequency of 30 kHz only during the first 30 seconds. | Device | Sham stimulation |
Primary outcome
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.
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.
Tactile Threshold
Time frame: Baseline at 0 minutes
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Pressure Pain Threshold
Time frame: Baseline at 0 minutes
The PPT will be measured with an algometer and will be expressed in Newtons
Muscle strength
Time frame: Baseline at 0 minutes
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
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
Pressure Pain Threshold
Time frame: During treatment at 15 minutes
The PPT will be measured with an algometer and will be expressed in Newtons
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.
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.
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
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
Muscle strength
Time frame: Immediately after treatment at 20 minutes
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
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.
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.
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
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
Muscle strength
Time frame: Immediately after treatment at 30 minutes
Muscle strength will be measured with a dynamometer and will be expressed in Kgs.
5 secondary outcomes
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
Numerical Discomfort Rate Score
Time frame: After the intervention at 35 minutes
Numerical Pain Rate Score
Time frame: After the intervention at 35 minutes
Number of participants with intervention-related adverse effects
Time frame: After the intervention at 35 minutes
Blinding success
Time frame: After the intervention at 35 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 36845426Alvarez DM, Serrano-Munoz D, Fernandez-Perez JJ, Gomez-Soriano J, Avendano-Coy J. Effect of percutaneous electrical stimulation with high-frequency alternating currents at 30 kHz on the sensory-motor system. Front Neurosci. 2023 Feb 9;17:1048986. doi: 10.3389/fnins.2023.1048986. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Avendaño-Coy, PhD study director
Castilla-La Mancha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 kHz stimulation (Myomed 932, Enraf-Nonius) in people with Electrical Stimulation and Neuromodulation, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency of Antidromic median sensory nerve action potential (time frame: Baseline at 0 minutes). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.