Nerve BlockNCT03169049
Nerve Conduction Block Using Transcutaneous Electrical Currents
A study testing High-Frequency Stimulation in people with Nerve Block and Electric Stimulation, run by University of Castilla-La Mancha.
Trial summary
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Electric Stimulation
- What is being tested?
- High-Frequency Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Sep 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
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- 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
No sites are listed yet.
About this study
Official title: Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.
Read the detailed description
In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents).
It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason the investigators decided to applied 20KHz to observe the effects on maximal manual force and to compare versus sham stimulation.
Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.
- Conditions
- Nerve Block, Electric Stimulation
- Being tested
- High-Frequency Stimulation, sham Stimulation
- Keywords
- nerve conduction block, high frequency stimulation, handgrip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency StimulationDevice
high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
sham StimulationDevice
Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| High-Frequency | Experimental | Transcutaneous application of high frequency electrical current over the arm 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: High-Frequency Stimulation |
| Sham stimulation | Sham comparator | Electrodes are placed over the arm for a 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel Receives: Device: sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Hand Muscle Strength
The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
Measured: Baseline at 0 min
Hand muscle strength after treatment 20 min
The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
Measured: After treatment 20 min
Secondary outcomes (1)
Change from baseline in Muscle strength
The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
Measured: baseline at 0 min, immediately after treatment at 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startJul 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
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 Nerve BlockStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Diego Serrano-Muñoz, MsC, Principal investigator, Hospital Nacional de Parapléjicos, Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169049
- Sponsor's protocol ID
- ddsm10
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. Effect of high-frequency alternating current transcutaneous stimulation over muscle strength: a controlled pilot study. J Neuroeng Rehabil. 2018 Nov 12;15(1):103. doi: 10.1186/s12984-018-0443-2.
PubMed 30419966
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03169049
- Acronym / sponsor ID
- ddsm10
- Conditions
- Nerve Block, Electric Stimulation
- Keywords
- nerve conduction block, high frequency stimulation, handgrip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- Jul 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 May 2017 (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.
The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.
Detailed description
In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents).
It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason the investigators decided to applied 20KHz to observe the effects on maximal manual force and to compare versus sham stimulation.
Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Frequency | Experimental | Device: High-Frequency StimulationTranscutaneous application of high frequency electrical current over the arm 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 comparator | Device: sham StimulationElectrodes are placed over the arm for a 20 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (11 listed)
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- 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 |
|---|---|---|
| High-Frequency Stimulationhigh-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | High-Frequency |
| sham StimulationSham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | Sham stimulation |
Primary outcome
Baseline Hand Muscle Strength
Time frame: Baseline at 0 min
The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
Hand muscle strength after treatment 20 min
Time frame: After treatment 20 min
The hand muscle strength will be measured with a dynamometer and will be expressed in Newton
1 secondary outcome
Change from baseline in Muscle strength
Time frame: baseline at 0 min, immediately after treatment at 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 30419966Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. Effect of high-frequency alternating current transcutaneous stimulation over muscle strength: a controlled pilot study. J Neuroeng Rehabil. 2018 Nov 12;15(1):103. doi: 10.1186/s12984-018-0443-2.
- Individual participant dataSharing planned: Undecided
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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.
Diego Serrano-Muñoz, MsC principal investigator
Hospital Nacional de Parapléjicos, Toledo
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency Stimulation in people with Nerve Block and Electric Stimulation, run by University of Castilla-La Mancha.
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 1 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: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Serrano-Muñoz, MsC (+34 925 24 77 00 ext. 47783, dserranomu@externas.sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Hand Muscle Strength (time frame: Baseline at 0 min). The study lists 2 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 NCT03169049, 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 30 May 2017.