Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects

Healthy Volunteers Clinical Trial

— ELECTRO-WP  

Official title:

Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857710
• Other study ID #: 20CH198
• Secondary ID: 2021-A00507-34
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 22, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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).
• 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).
• Control (CONT) modality
Control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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