Electrical StimulationNCT04200677
Influence of Electrode Positioning and Current Type on Fatigue, Force and Discomfort
A study testing Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve, Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve and Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve in people with Electrical Stimulation, run by University of Brasilia at 2 sites in Brazil.
Trial summary
Introduction: Neuromuscular electrical stimulation (NMES) has the purpose of generating muscle contractions to minimize muscular atrophy and to improve neuromuscular performance. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Stimulation
- What is being tested?
- Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve, Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve and Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBrazil
- Study dates
- 10 Jan 2020to 1 May 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY;
- To practice only recreational physical activity;
- Be at least 3 months without practicing strength training.
Who cannot join
- Present some type of skeletal muscle dysfunction that may interfere with the tests;
- NMES intolerance in the triceps surae muscle belly or tibial nerve;
- Use of analgesics, antidepressants, tranquilizers or other centrally acting agents;
- Cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular disorders that may hinder the complete execution of the study design by the volunteer.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of Brasília
Brasília, Federal District, 72220-900
Faculty of Physical Education
Brasília, Federal District
About this study
Official title: Influence of Electrode Positioning and Current Type on Muscle Fatigability, Force Generation, Perceived Discomfort and Neuromuscular Adaptations Induced by Neuromuscular Electric Stimulation: Implications on Rehabilitation
Introduction: Neuromuscular electrical stimulation (NMES) has the purpose of generating muscle contractions to minimize muscular atrophy and to improve neuromuscular performance. NMES has been performed using monophasic or biphasic currents, applied over a nerve trunk or muscle belly, and both can generate contractions by the peripheral and central nervous system. Pulse width (wide or narrow) is an essential parameter for NMES. Although NMES studies using wide pulses have been performed with monophasic currents, it is known that this current induces discomfort during NMES. Therefore, it is necessary to analyze if biphasic currents have the same effect as monophasic currents using the same parameters.
Objectives:
Read more
To compare the effects of NMES with narrow and wide pulse widths associated with monophasic and biphasic currents, applied over a tibial nerve and triceps surae muscles in healthy individuals in terms of muscle fatigue, central and peripheral contribution, voluntary and evoked force and sensory discomfort.
Methods:
A crossover, experimental controlled and randomized study will be developed with healthy male and female (age: 18-45 years). The following dependent variables will be: amplitude of H-reflex and M-wave (single and double pulses), voluntary and evoked triceps surae muscles torque, fatigability (force time integral), perceived discomfort and neuromuscular adaptations. The independent variables will be related to current phase, pulse width and location of electrical stimulation electrodes. There will be a familiarization session followed by 9 sessions with 7 rest days between them (10 weeks). Data will be reported as mean and standard deviation (± SD). Parametric tests will be used for the normally distributed data (Shapiro-Wilk test) that show homogeneous variations (Levene test). A repeated measure mixed-model ANOVA will be performed and, in the case of major effects or significant interactions, the Tukey post-hoc test will be applied. In addition, the power and size of the effect (reported as partial eta square, partial η2) will be calculated. The significance threshold will be set at p <0.05 for all procedures.
Expected results: Biphasic currents will be more comfortable and will generate less muscle fatigue when compared to monophasic currents. There will be less fatigue and greater central contribution when wider pulse currents will be applied over a nerve trunk concerning the application with a wide pulse over a muscle belly.
Read the detailed description
This is a randomized controlled trial, a crossover study, with healthy male and female participants. The procedures will take place in 10 distinct visits for a 7-day interval.
The following visit in the lab will be:
- Familiarization session.
- Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve;
- Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve;
- Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve;
- Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve;
- Monophasic (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly;
- Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly;
- Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly;
- Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly;
- Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly.
The dependent variables will be:
- Muscle fatigability;
- Central and peripheral contribution (with H-reflex and M-wave amplitude analysis);
- Maximum voluntary isometric contraction;
- Force production for plantar flexion evoked by NMES;
- Perceived discomfort.
- Conditions
- Electrical Stimulation
- Being tested
- Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve, Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve, Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve, Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve, Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial NerveOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following NMES parameters: (Monophasic Current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial NerveOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial NerveOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial NerveOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s)
Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle BellyOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Monophasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle BellyOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle BellyOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle BellyOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s)
Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle BellyOther
The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 25 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
| Study group | Role | What they receive |
|---|---|---|
| MCN1 | Experimental | Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve Receives: Other: Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve |
| BCN05 | Experimental | Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve Receives: Other: Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve |
| BCN1 | Experimental | Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve Receives: Other: Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve |
| BCN2 | Experimental | Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve Receives: Other: Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve |
| MCM1 | Experimental | Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly Receives: Other: Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly |
| BCM05 | Experimental | Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly Receives: Other: Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly |
| BCM1 | Experimental | Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly Receives: Other: Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly |
| BCM2 | Experimental | Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly Receives: Other: Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly |
| BC25 | Experimental | Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly Receives: Other: Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Fatigue
Muscle Fatigue will be assessed by Force time integral (area under the force trace), after neuromuscular electrical stimulation protocol.
Measured: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Muscle Force
Muscle force will be assessed by muscle force changes, based on the torque generated pre and post neuromuscular electrical stimulation protocol.
Measured: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Change from Baseline Central contribution (H reflex amplitude) after 15 minutes session of NMES
Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the session.
Measured: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Change from Baseline Peripheral contribution (M wave amplitude) after 15 minutes session of NMES
Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the session.
Measured: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Change from Baseline Evoked Torque after 15 minutes session of electrical stimulation
Evoked Torque will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the session.
Measured: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Discomfort
Discomfort sensory will be evaluated by Visual Analogic Scale during and after the evoked torque measurement with NMES. The Visual Analogic Scale assess pain by rating the subjective perceived discomfort of the subject from 0 (no perceived discomfort) to 10 (the most perceived discomfort)
Measured: At the beginning, middle and end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start10 Jan 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Luiz Q. Durigan, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200677
- Sponsor's protocol ID
- CAAE: 14734619.3.0000.8093
- Status last verified
- May 2023
- First submitted
- 5 Dec 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ward AR, Robertson VJ. The variation in fatigue rate with frequency using kHz frequency alternating current. Med Eng Phys. 2000 Nov;22(9):637-46. doi: 10.1016/s1350-4533(00)00085-0.
PubMed 11259932Aldayel A, Jubeau M, McGuigan M, Nosaka K. Comparison between alternating and pulsed current electrical muscle stimulation for muscle and systemic acute responses. J Appl Physiol (1985). 2010 Sep;109(3):735-44. doi: 10.1152/japplphysiol.00189.2010. Epub 2010 Jul 1.
PubMed 20595542Ward AR, Lucas-Toumbourou S, McCarthy B. A comparison of the analgesic efficacy of medium-frequency alternating current and TENS. Physiotherapy. 2009 Dec;95(4):280-8. doi: 10.1016/j.physio.2009.06.005. Epub 2009 Sep 2.
PubMed 19892092Selkowitz DM, Rossman EG, Fitzpatrick S. Effect of burst-modulated alternating current carrier frequency on current amplitude required to produce maximally tolerated electrically stimulated quadriceps femoris knee extension torque. Am J Phys Med Rehabil. 2009 Dec;88(12):973-8. doi: 10.1097/PHM.0b013e3181c1eda5.
PubMed 19935181Ward AR, Shkuratova N. Russian electrical stimulation: the early experiments. Phys Ther. 2002 Oct;82(10):1019-30.
PubMed 12350217Bergquist AJ, Clair JM, Collins DF. Motor unit recruitment when neuromuscular electrical stimulation is applied over a nerve trunk compared with a muscle belly: triceps surae. J Appl Physiol (1985). 2011 Mar;110(3):627-37. doi: 10.1152/japplphysiol.01103.2010. Epub 2010 Dec 23.
PubMed 21183628Collins DF. Central contributions to contractions evoked by tetanic neuromuscular electrical stimulation. Exerc Sport Sci Rev. 2007 Jul;35(3):102-9. doi: 10.1097/jes.0b013e3180a0321b.
PubMed 17620928Martin A, Grospretre S, Vilmen C, Guye M, Mattei JP, LE Fur Y, Bendahan D, Gondin J. The Etiology of Muscle Fatigue Differs between Two Electrical Stimulation Protocols. Med Sci Sports Exerc. 2016 Aug;48(8):1474-84. doi: 10.1249/MSS.0000000000000930.
PubMed 27031743Neyroud D, Dodd D, Gondin J, Maffiuletti NA, Kayser B, Place N. Wide-pulse-high-frequency neuromuscular stimulation of triceps surae induces greater muscle fatigue compared with conventional stimulation. J Appl Physiol (1985). 2014 May 15;116(10):1281-9. doi: 10.1152/japplphysiol.01015.2013. Epub 2014 Mar 27.
PubMed 24674861Regina Dias Da Silva S, Neyroud D, Maffiuletti NA, Gondin J, Place N. Twitch potentiation induced by two different modalities of neuromuscular electrical stimulation: implications for motor unit recruitment. Muscle Nerve. 2015 Mar;51(3):412-8. doi: 10.1002/mus.24315. Epub 2015 Jan 5.
PubMed 24917022Wegrzyk J, Foure A, Le Fur Y, Maffiuletti NA, Vilmen C, Guye M, Mattei JP, Place N, Bendahan D, Gondin J. Responders to Wide-Pulse, High-Frequency Neuromuscular Electrical Stimulation Show Reduced Metabolic Demand: A 31P-MRS Study in Humans. PLoS One. 2015 Nov 30;10(11):e0143972. doi: 10.1371/journal.pone.0143972. eCollection 2015.
PubMed 26619330Wegrzyk J, Foure A, Vilmen C, Ghattas B, Maffiuletti NA, Mattei JP, Place N, Bendahan D, Gondin J. Extra Forces induced by wide-pulse, high-frequency electrical stimulation: Occurrence, magnitude, variability and underlying mechanisms. Clin Neurophysiol. 2015 Jul;126(7):1400-12. doi: 10.1016/j.clinph.2014.10.001. Epub 2014 Oct 13.
PubMed 25454283Kiernan MC, Lin CS, Burke D. Differences in activity-dependent hyperpolarization in human sensory and motor axons. J Physiol. 2004 Jul 1;558(Pt 1):341-9. doi: 10.1113/jphysiol.2004.063966. Epub 2004 May 14.
PubMed 15146048Kiernan MC, Mogyoros I, Burke D. Differences in the recovery of excitability in sensory and motor axons of human median nerve. Brain. 1996 Aug;119 ( Pt 4):1099-105. doi: 10.1093/brain/119.4.1099.
PubMed 8813274Alexandre F, Derosiere G, Papaiordanidou M, Billot M, Varray A. Cortical motor output decreases after neuromuscular fatigue induced by electrical stimulation of the plantar flexor muscles. Acta Physiol (Oxf). 2015 May;214(1):124-34. doi: 10.1111/apha.12478. Epub 2015 Mar 18.
PubMed 25740017
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Electrode Positioning and Current Type on Muscle Fatigability, Force Generation, Perceived Discomfort and Neuromuscular Adaptations Induced by Neuromuscular Electric Stimulation: Implications on Rehabilitation
- ClinicalTrials.gov ID
- NCT04200677
- Acronym / sponsor ID
- CAAE: 14734619.3.0000.8093
- Conditions
- Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 16 Dec 2019 (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.
Introduction: Neuromuscular electrical stimulation (NMES) has the purpose of generating muscle contractions to minimize muscular atrophy and to improve neuromuscular performance. NMES has been performed using monophasic or biphasic currents, applied over a nerve trunk or muscle belly, and both can generate contractions by the peripheral and central nervous system. Pulse width (wide or narrow) is an essential parameter for NMES. Although NMES studies using wide pulses have been performed with monophasic currents, it is known that this current induces discomfort during NMES. Therefore, it is necessary to analyze if biphasic currents have the same effect as monophasic currents using the same parameters.
Objectives:
To compare the effects of NMES with narrow and wide pulse widths associated with monophasic and biphasic currents, applied over a tibial nerve and triceps surae muscles in healthy individuals in terms of muscle fatigue, central and peripheral contribution, voluntary and evoked force and sensory discomfort.
Methods:
A crossover, experimental controlled and randomized study will be developed with healthy male and female (age: 18-45 years). The following dependent variables will be: amplitude of H-reflex and M-wave (single and double pulses), voluntary and evoked triceps surae muscles torque, fatigability (force time integral), perceived discomfort and neuromuscular adaptations. The independent variables will be related to current phase, pulse width and location of electrical stimulation electrodes. There will be a familiarization session followed by 9 sessions with 7 rest days between them (10 weeks). Data will be reported as mean and standard deviation (± SD). Parametric tests will be used for the normally distributed data (Shapiro-Wilk test) that show homogeneous variations (Levene test). A repeated measure mixed-model ANOVA will be performed and, in the case of major effects or significant interactions, the Tukey post-hoc test will be applied. In addition, the power and size of the effect (reported as partial eta square, partial η2) will be calculated. The significance threshold will be set at p <0.05 for all procedures.
Expected results: Biphasic currents will be more comfortable and will generate less muscle fatigue when compared to monophasic currents. There will be less fatigue and greater central contribution when wider pulse currents will be applied over a nerve trunk concerning the application with a wide pulse over a muscle belly.
Detailed description
This is a randomized controlled trial, a crossover study, with healthy male and female participants. The procedures will take place in 10 distinct visits for a 7-day interval.
The following visit in the lab will be:
- Familiarization session.
- Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve;
- Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve;
- Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve;
- Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve;
- Monophasic (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly;
- Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly;
- Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly;
- Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly;
- Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly.
The dependent variables will be:
- Muscle fatigability;
- Central and peripheral contribution (with H-reflex and M-wave amplitude analysis);
- Maximum voluntary isometric contraction;
- Force production for plantar flexion evoked by NMES;
- Perceived discomfort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| MCN1 | Experimental | Other: Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial NerveMonophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve |
| BCN05 | Experimental | Other: Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial NerveBiphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve |
| BCN1 | Experimental | Other: Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial NerveBiphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve |
| BCN2 | Experimental | Other: Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial NerveBiphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve |
| MCM1 | Experimental | Other: Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle BellyMonophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly |
| BCM05 | Experimental | Other: Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle BellyBiphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly |
| BCM1 | Experimental | Other: Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle BellyBiphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly |
| BCM2 | Experimental | Other: Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle BellyBiphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly |
| BC25 | Experimental | Other: Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle BellyBiphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY;
- To practice only recreational physical activity;
- Be at least 3 months without practicing strength training.
Key exclusion criteria (4 listed)
- Present some type of skeletal muscle dysfunction that may interfere with the tests;
- NMES intolerance in the triceps surae muscle belly or tibial nerve;
- Use of analgesics, antidepressants, tranquilizers or other centrally acting agents;
- Cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular disorders that may hinder the complete execution of the study design by the volunteer.
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 |
|---|---|---|
| Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial NerveThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following NMES parameters: (Monophasic Current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s) | Other | MCN1 |
| Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial NerveThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s) | Other | BCN05 |
| Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial NerveThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s) | Other | BCN1 |
| Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial NerveThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s) | Other | BCN2 |
| Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle BellyThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Monophasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s) | Other | MCM1 |
| Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle BellyThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s) | Other | BCM05 |
| Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle BellyThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s) | Other | BCM1 |
| Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle BellyThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s) | Other | BCM2 |
| Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle BellyThe participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 25 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s) | Other | BC25 |
Primary outcome
Muscle Fatigue
Time frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Muscle Fatigue will be assessed by Force time integral (area under the force trace), after neuromuscular electrical stimulation protocol.
Muscle Force
Time frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Muscle force will be assessed by muscle force changes, based on the torque generated pre and post neuromuscular electrical stimulation protocol.
Change from Baseline Central contribution (H reflex amplitude) after 15 minutes session of NMES
Time frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the session.
Change from Baseline Peripheral contribution (M wave amplitude) after 15 minutes session of NMES
Time frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the session.
Change from Baseline Evoked Torque after 15 minutes session of electrical stimulation
Time frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Evoked Torque will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the session.
Discomfort
Time frame: At the beginning, middle and end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).
Discomfort sensory will be evaluated by Visual Analogic Scale during and after the evoked torque measurement with NMES. The Visual Analogic Scale assess pain by rating the subjective perceived discomfort of the subject from 0 (no perceived discomfort) to 10 (the most perceived discomfort)
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 24 May 2023.
- Background: PubMed 11259932Ward AR, Robertson VJ. The variation in fatigue rate with frequency using kHz frequency alternating current. Med Eng Phys. 2000 Nov;22(9):637-46. doi: 10.1016/s1350-4533(00)00085-0.
- Background: PubMed 20595542Aldayel A, Jubeau M, McGuigan M, Nosaka K. Comparison between alternating and pulsed current electrical muscle stimulation for muscle and systemic acute responses. J Appl Physiol (1985). 2010 Sep;109(3):735-44. doi: 10.1152/japplphysiol.00189.2010. Epub 2010 Jul 1.
- Background: PubMed 19892092Ward AR, Lucas-Toumbourou S, McCarthy B. A comparison of the analgesic efficacy of medium-frequency alternating current and TENS. Physiotherapy. 2009 Dec;95(4):280-8. doi: 10.1016/j.physio.2009.06.005. Epub 2009 Sep 2.
- Background: PubMed 19935181Selkowitz DM, Rossman EG, Fitzpatrick S. Effect of burst-modulated alternating current carrier frequency on current amplitude required to produce maximally tolerated electrically stimulated quadriceps femoris knee extension torque. Am J Phys Med Rehabil. 2009 Dec;88(12):973-8. doi: 10.1097/PHM.0b013e3181c1eda5.
- Background: PubMed 12350217Ward AR, Shkuratova N. Russian electrical stimulation: the early experiments. Phys Ther. 2002 Oct;82(10):1019-30.
- Background: PubMed 21183628Bergquist AJ, Clair JM, Collins DF. Motor unit recruitment when neuromuscular electrical stimulation is applied over a nerve trunk compared with a muscle belly: triceps surae. J Appl Physiol (1985). 2011 Mar;110(3):627-37. doi: 10.1152/japplphysiol.01103.2010. Epub 2010 Dec 23.
- Background: PubMed 17620928Collins DF. Central contributions to contractions evoked by tetanic neuromuscular electrical stimulation. Exerc Sport Sci Rev. 2007 Jul;35(3):102-9. doi: 10.1097/jes.0b013e3180a0321b.
- Background: PubMed 27031743Martin A, Grospretre S, Vilmen C, Guye M, Mattei JP, LE Fur Y, Bendahan D, Gondin J. The Etiology of Muscle Fatigue Differs between Two Electrical Stimulation Protocols. Med Sci Sports Exerc. 2016 Aug;48(8):1474-84. doi: 10.1249/MSS.0000000000000930.
- Background: PubMed 24674861Neyroud D, Dodd D, Gondin J, Maffiuletti NA, Kayser B, Place N. Wide-pulse-high-frequency neuromuscular stimulation of triceps surae induces greater muscle fatigue compared with conventional stimulation. J Appl Physiol (1985). 2014 May 15;116(10):1281-9. doi: 10.1152/japplphysiol.01015.2013. Epub 2014 Mar 27.
- Background: PubMed 24917022Regina Dias Da Silva S, Neyroud D, Maffiuletti NA, Gondin J, Place N. Twitch potentiation induced by two different modalities of neuromuscular electrical stimulation: implications for motor unit recruitment. Muscle Nerve. 2015 Mar;51(3):412-8. doi: 10.1002/mus.24315. Epub 2015 Jan 5.
- Background: PubMed 26619330Wegrzyk J, Foure A, Le Fur Y, Maffiuletti NA, Vilmen C, Guye M, Mattei JP, Place N, Bendahan D, Gondin J. Responders to Wide-Pulse, High-Frequency Neuromuscular Electrical Stimulation Show Reduced Metabolic Demand: A 31P-MRS Study in Humans. PLoS One. 2015 Nov 30;10(11):e0143972. doi: 10.1371/journal.pone.0143972. eCollection 2015.
- Background: PubMed 25454283Wegrzyk J, Foure A, Vilmen C, Ghattas B, Maffiuletti NA, Mattei JP, Place N, Bendahan D, Gondin J. Extra Forces induced by wide-pulse, high-frequency electrical stimulation: Occurrence, magnitude, variability and underlying mechanisms. Clin Neurophysiol. 2015 Jul;126(7):1400-12. doi: 10.1016/j.clinph.2014.10.001. Epub 2014 Oct 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve, Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve and Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve in people with Electrical Stimulation, run by University of Brasilia at 2 sites in Brazil.
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 3 inclusion and 4 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Muscle Fatigue (time frame: Change from baseline to the end of thirty-six contractions evoked by electrical stimulation (1 per week, total of 9 sessions). This outcome will be measured up to 9 weeks. Data will be reported through study completion (4 years).). The study lists 6 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 NCT04200677, which also lists 20 linked publications.
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 24 May 2023; AzTrials last refreshed its copy on 1 Nov 2026.