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

NCT ID: NCT04857710

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-08-22

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control (CONT)

A control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations

Group Type: ACTIVE_COMPARATOR

Control (CONT) modality

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Conventional neuromuscular electrostimulation (CONV NMES)

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Wide-pulse neuromuscular electrostimulation (WP NMES)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Control (CONT) modality

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Léonard FEASSON, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Saint-Etienne

Thomas LAPOLE, PhD

Role: STUDY_DIRECTOR

Université de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2021-A00507-34

Identifier Type: OTHER

Identifier Source: secondary_id

20CH198

Identifier Type: -

Identifier Source: org_study_id