Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects (ELECTRO-WP)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Control (CONT) modality; Device: Conventional neuromuscular electrostimulation (CONV NMES); Device: Wide-pulse neuromuscular electrostimulation (WP NMES)

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42000
    • Chu de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Affiliates or beneficiaries of a social security scheme
• Having freely given their written consent

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control (CONT); A control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations	Device: Control (CONT) modality; Control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations.
EXPERIMENTAL: Conventional neuromuscular electrostimulation (CONV); 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.	Device: 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).
EXPERIMENTAL: Wide-pulse neuromuscular electrostimulation (WP); 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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement	Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle	week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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.	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.	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.	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.	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.	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.	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.	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.	week 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Léonard FEASSON, MD PHD, CENTRE HOSPITALIER DE SAINT-ETIENNE; Study Director: Thomas LAPOLE, PhD, Université de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2021
• Primary Completion (ACTUAL): May 9, 2022
• Study Completion (ACTUAL): August 22, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Training; Neuromuscular electrostimulation; Wide-pulse; Strength gain; Neuromuscular adaptations
• Other Study ID Numbers: 20CH198; 2021-A00507-34 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No