Healthy VolunteersELECTRO-WPNCT04857710
Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects
A study testing Wide-pulse neuromuscular electrostimulation (WP NMES) and Conventional neuromuscular electrostimulation (CONV NMES) in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group.The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Wide-pulse neuromuscular electrostimulation (WP NMES) and Conventional neuromuscular electrostimulation (CONV NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2021to 22 Aug 2022
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Affiliates or beneficiaries of a social security scheme
- Having freely given their written consent
Who cannot join
- Disease or surgery resulting in a locomotor disorder, within 6 months prior to the study
- Chronic neurological, motor or psychic diseases
- Taking neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) for the duration of the study
- Contraindication to neuromuscular electrostimulation
- Contraindication to magnetic stimulation
- Participation at the same time in another interventional experiment or having participated in such a study within 30 days prior to this study
- Sports (>10 hours per week or strength training of the lower limbs)
Trial locations and contacts
1 site in 1 country.
About this study
Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group.The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit. The first aim of this study is to evaluate and compare the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks.The second aim is to understand the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements.
Read the detailed description
Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group. The conventional (CONV) parameters of NMES induces a direct activation of the muscle fibers located close to the stimulation electrodes. This means that the neuromuscular system is not fully solicited, which limits its adaptation. The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit.
The first aim of this study is to evaluate and compare the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks. The second aim is to understand the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements. To consolidate the benefit of NMES programs, a control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations. The CONV modality allows us to compare with the current clinical application and the majority of the literature on the adaptations induced by NMES training. Finally, the WP modality aims to assess the possible benefits linked to the use of wide-pulses during the application of NMES. A clinical transfer will then be envisaged to confirm the interest and benefits of this type of program. We hypothesise that nervous adaptations will be increased by the use of WP NMES, leading to greater gains in strength and functional benefits than with CONV NMES.
- Conditions
- Healthy Volunteers
- Being tested
- Wide-pulse neuromuscular electrostimulation (WP NMES), Conventional neuromuscular electrostimulation (CONV NMES), Control (CONT) modality
- Keywords
- Wide-pulse, Training, Strength gain, Neuromuscular adaptations, Neuromuscular electrostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide-pulse neuromuscular electrostimulation (WP NMES)Device
The WP NMES program consists of electrical stimulation trains of 1000 symmetrical biphasic pulses (1 ms, 100 Hz). The duration of a train is of 10 s and the rest between trains is of 30 s. A WP NMES session includes 30 evoked contractions. The stimulation intensity is monitored online and adjusted to the highest tolerable by the subjects.During the stimulation, subjects are seated with the knee joint fixed a 60° angle. Three self-adhesive electrodes are placed over the right thigh. The positive electrodes, measuring 25 cm² (5 x 5 cm), are placed as close as possible to the motor point of the vastus lateralis and vastus medialis muscles. The negative electrode, measuring 50 cm² (10 x 5 cm), is placed 5-7 cm below the inguinal ligament. Electrical stimulations are delivered by a stimulator BioStim (Mazet Santé).
Conventional neuromuscular electrostimulation (CONV NMES)Device
The CONV NMES program consists of electrical stimulation trains of 500 symmetrical biphasic pulses (0.2 ms, 50 Hz). The duration of a train is of 10 s and the rest between trains is of 30 s (duty cycle: 1/3). A WP NMES session includes 30 evoked contractions. The stimulation intensity is monitored online and adjusted to the highest tolerable by the subjects.
During the stimulation, subjects are seated with the knee joint fixed a 60° angle. Three self-adhesive electrodes are placed over the right thigh. The positive electrodes, measuring 25 cm² (5 x 5 cm), are placed as close as possible to the motor point of the vastus lateralis and vastus medialis muscles. The negative electrode, measuring 50 cm² (10 x 5 cm), is placed 5-7 cm below the inguinal ligament. Electrical stimulations are delivered by a stimulator BioStim (Mazet Santé).
Control (CONT) modalityDevice
Control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations.
| Study group | Role | What they receive |
|---|---|---|
| Control (CONT) | Active comparator | A control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations Receives: Device: Control (CONT) modality |
| Conventional neuromuscular electrostimulation (CONV) | Experimental | The CONV (conventional) modality allows us to compare with the current clinical application and the majority of the literature on the adaptations induced by NMES (neuromuscular electrostimulation) training. Receives: Device: Conventional neuromuscular electrostimulation (CONV NMES) |
| Wide-pulse neuromuscular electrostimulation (WP) | Experimental | The use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit. Receives: Device: Wide-pulse neuromuscular electrostimulation (WP NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle
Measured: week 6
Secondary outcomes (12)
Voluntary activation measurement (%)
The level of voluntary activation will be determined by the force increment obtained following stimulation performed during a condition of the muscle in a state of maximum contraction.
Measured: week 6
Voluntary activation measurement (%)
The level of voluntary activation will be determined by the force increment obtained following stimulation performed during a condition of the muscle in a state of maximum contraction.
Measured: week 12
Cortico-spinal excitability measurement
The quantification of cortico-spinal excitability (i.e. motor evoked potentials, in mV) will be evaluated by recording the electromyographic responses (surface EMG) evoked by transcranial magnetic stimulation
Measured: week 6
Cortico-spinal excitability measurement
The quantification of cortico-spinal excitability (i.e. motor evoked potentials, in mV) will be evaluated by recording the electromyographic responses (surface EMG) evoked by transcranial magnetic stimulation
Measured: week 12
Spinal excitability measurement
The quantification of spinal excitability (i.e. spinal reflex, in mV) will be evaluated by recording the EMG responses evoked by electrical stimulation in the lumbar vertebrae.
The quantification of spinal excitability (i.e. spinal reflex, in mV) will be evaluated by recording the EMG responses evoked by electrical stimulation in the lumbar vertebrae.
Measured: week 6
Spinal excitability measurement
The quantification of spinal excitability (i.e. spinal reflex, in mV) will be evaluated by recording the EMG responses evoked by electrical stimulation in the lumbar vertebrae.
The quantification of spinal excitability (i.e. spinal reflex, in mV) will be evaluated by recording the EMG responses evoked by electrical stimulation in the lumbar vertebrae.
Measured: week 12
Muscular endurance measurement
Muscle endurance (number of contractions performed before failure) will be assessed during a fatigue protocol consisting of performing quadriceps muscle contractions at incremental strength levels.
Measured: week 6
Muscular endurance measurement
Muscle endurance (number of contractions performed before failure) will be assessed during a fatigue protocol consisting of performing quadriceps muscle contractions at incremental strength levels.
Measured: week 12
Jump performances measurement
The performance of jumps (height, in cm; length, in cm) will be evaluated during various tests of vertical (Squat Jump and Counter Movement Jump) and horizontal (Single Hop and Triple Hop) jumps.
Measured: week 6
Jump performances measurement
The performance of jumps (height, in cm; length, in cm) will be evaluated during various tests of vertical (Squat Jump and Counter Movement Jump) and horizontal (Single Hop and Triple Hop) jumps.
Measured: week 12
Postural balance performances measurement
The postural balance performance (displacement of the center of pressure, in mm) will be evaluated during a unipodal postural balance test performed on a force platform.
Measured: week 6
Postural balance performances measurement
The postural balance performance (displacement of the center of pressure, in mm) will be evaluated during a unipodal postural balance test performed on a force platform.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start5 May 2021
- Primary completion9 May 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Model description
- Evaluating and comparing the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks. Understanding the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements. To consolidate the benefit of NMES programs, a control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations. The CONV modality allows us to compare with the current clinical application and the majority of the literature on the adaptations induced by NMES training. Finally, the WP modality aims to assess the possible benefits linked to the use of wide-pulses during the application of NMES.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léonard FEASSON, MD PHD, Principal investigator, Centre Hospitalier de Saint-EtienneThomas LAPOLE, PhD, Study director, Université de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857710
- Sponsor's protocol ID
- 20CH198
- Other IDs
- 2021-A00507-34
- Acronym
- ELECTRO-WP
- Status last verified
- Sep 2022
- First submitted
- 20 Apr 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04857710
- Acronym / sponsor ID
- ELECTRO-WP / 20CH198
- Conditions
- Healthy Volunteers
- Keywords
- Wide-pulse, Training, Strength gain, Neuromuscular adaptations, Neuromuscular electrostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 23 Apr 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.
Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group.The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit. The first aim of this study is to evaluate and compare the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks.The second aim is to understand the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements.
Detailed description
Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group. The conventional (CONV) parameters of NMES induces a direct activation of the muscle fibers located close to the stimulation electrodes. This means that the neuromuscular system is not fully solicited, which limits its adaptation. The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit.
The first aim of this study is to evaluate and compare the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks. The second aim is to understand the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements. To consolidate the benefit of NMES programs, a control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations. The CONV modality allows us to compare with the current clinical application and the majority of the literature on the adaptations induced by NMES training. Finally, the WP modality aims to assess the possible benefits linked to the use of wide-pulses during the application of NMES. A clinical transfer will then be envisaged to confirm the interest and benefits of this type of program. We hypothesise that nervous adaptations will be increased by the use of WP NMES, leading to greater gains in strength and functional benefits than with CONV NMES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Evaluating and comparing the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks. Understanding the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements. To consolidate the benefit of NMES programs, a control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations. The CONV modality allows us to compare with the current clinical application and the majority of the literature on the adaptations induced by NMES training. Finally, the WP modality aims to assess the possible benefits linked to the use of wide-pulses during the application of NMES.
| Arm | Type | Receives |
|---|---|---|
| Control (CONT) | Active comparator | Device: Control (CONT) modalityA control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations |
| Conventional neuromuscular electrostimulation (CONV) | Experimental | Device: Conventional neuromuscular electrostimulation (CONV NMES)The CONV (conventional) modality allows us to compare with the current clinical application and the majority of the literature on the adaptations induced by NMES (neuromuscular electrostimulation) training. |
| Wide-pulse neuromuscular electrostimulation (WP) | Experimental | Device: Wide-pulse neuromuscular electrostimulation (WP NMES)The use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Affiliates or beneficiaries of a social security scheme
- Having freely given their written consent
Key exclusion criteria (7 listed)
- Disease or surgery resulting in a locomotor disorder, within 6 months prior to the study
- Chronic neurological, motor or psychic diseases
- Taking neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) for the duration of the study
- Contraindication to neuromuscular electrostimulation
- Contraindication to magnetic stimulation
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 |
|---|---|---|
| Wide-pulse neuromuscular electrostimulation (WP NMES)The WP NMES program consists of electrical stimulation trains of 1000 symmetrical biphasic pulses (1 ms, 100 Hz). The duration of a train is of 10 s and the rest between trains is of 30 s. A WP NMES session includes 30 evoked contractions. The stimulation intensity is monitored online and adjusted to the highest tolerable by the subjects.During the stimulation, subjects are seated with the knee joint fixed a 60° angle. Three self-adhesive electrodes are placed over the right thigh. The positive electrodes, measuring 25 cm² (5 x 5 cm), are placed as close as possible to the motor point of the vastus lateralis and vastus medialis muscles. The negative electrode, measuring 50 cm² (10 x 5 cm), is placed 5-7 cm below the inguinal ligament. Electrical stimulations are delivered by a stimulator BioStim (Mazet Santé). | Device | Wide-pulse neuromuscular electrostimulation (WP) |
| Conventional neuromuscular electrostimulation (CONV NMES)The CONV NMES program consists of electrical stimulation trains of 500 symmetrical biphasic pulses (0.2 ms, 50 Hz). The duration of a train is of 10 s and the rest between trains is of 30 s (duty cycle: 1/3). A WP NMES session includes 30 evoked contractions. The stimulation intensity is monitored online and adjusted to the highest tolerable by the subjects. During the stimulation, subjects are seated with the knee joint fixed a 60° angle. Three self-adhesive electrodes are placed over the right thigh. The positive electrodes, measuring 25 cm² (5 x 5 cm), are placed as close as possible to the motor point of the vastus lateralis and vastus medialis muscles. The negative electrode, measuring 50 cm² (10 x 5 cm), is placed 5-7 cm below the inguinal ligament. Electrical stimulations are delivered by a stimulator BioStim (Mazet Santé). | Device | Conventional neuromuscular electrostimulation (CONV) |
| Control (CONT) modalityControl (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations. | Device | Control (CONT) |
Primary outcome
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Time frame: week 6
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle
12 secondary outcomes
Voluntary activation measurement (%)
Time frame: week 6
Voluntary activation measurement (%)
Time frame: week 12
Cortico-spinal excitability measurement
Time frame: week 6
Cortico-spinal excitability measurement
Time frame: week 12
Spinal excitability measurement
Time frame: week 6
Spinal excitability measurement
Time frame: week 12
Muscular endurance measurement
Time frame: week 6
Muscular endurance measurement
Time frame: week 12
Jump performances measurement
Time frame: week 6
Jump performances measurement
Time frame: week 12
Postural balance performances measurement
Time frame: week 6
Postural balance performances measurement
Time frame: week 12
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 14 Sep 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Léonard FEASSON, MD PHD principal investigator
Centre Hospitalier de Saint-Etienne
Thomas LAPOLE, PhD study director
Université de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide-pulse neuromuscular electrostimulation (WP NMES) and Conventional neuromuscular electrostimulation (CONV NMES) in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 inclusion and 7 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 14 Sep 2022. 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 France. 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?
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2022.