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

NCT04857710 | Completed

• 2 other identifiers: 20CH1982021-A00507-34
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Wide-pulse; Training; Strength gain; Neuromuscular adaptations; Neuromuscular electrostimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Voluntary activation measurement (%)

  week 6

• Voluntary activation measurement (%)

  week 12

• Cortico-spinal excitability measurement

  week 6

• Cortico-spinal excitability measurement

  week 12

• Spinal excitability measurement

  week 6

Study Arms (3)

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

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.

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.

Device: Wide-pulse neuromuscular electrostimulation (WP NMES)

Interventions

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).

Wide-pulse neuromuscular electrostimulation (WP)

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).

Conventional neuromuscular electrostimulation (CONV)

Control (CONT) modality DEVICE

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

Control (CONT)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Study Officials

• Léonard FEASSON, MD PHD

  Centre Hospitalier de Saint-Etienne

  PRINCIPAL INVESTIGATOR

• Thomas LAPOLE, PhD

  Université de Saint-Etienne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: May 5, 2021
• Primary Completion: May 9, 2022
• Study Completion: August 22, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)