Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy

December 4, 2013 updated by: Assistance Publique Hopitaux De Marseille
Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring, maintaining and/or enhancing muscular performance. From a practical point of view, NMES can elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or by the recruitment of motoneurons in the spinal cord through the depolarization of sensory axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance between transmission along these two pathways. Conventional NMES is usually delivered using short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus intensities so that the large antidromic volley in motor axons ensures that the evoked contraction will be driven largely by the direct depolarization of motor axons beneath the stimulation site with no or little involvement of central nervous system. On the contrary, when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz) (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the corresponding force (recently referred to as "extra force") is significantly (three times) larger than the conventional NMES-induced force. This extra force is supposed to represent the central contribution from the recruitment of spinal motoneurons by the evoked afferent volley given that no additional force was observed during a complete anesthetic block of the nerve proximal to the stimulation site. Despite the obvious differences in terms of activation of the neuromuscular system between conventional and WP-HF NMES, the functional, metabolic and cortical responses associated to both protocols remain to be determined

Study Overview

Detailed Description

The main goal of the project will be to characterize the evoked-force profile during conventional and WP-HF NMES.

The secondary purpose will be to i) investigate the anatomic and metabolic responses of the human calf muscle following both NMES protocols by using magnetic resonance imaging (MRI) and 31-phosphorous magnetic resonance spectroscopy (MRS-P31), ii) study the cortical responses for both conditions of stimulation by means of functional MRI (f-MRI).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age included between 18 and 45 years
  • The volunteers will have to benefit from a social security cover.
  • The selected subjects will have to be unhurt of any general disease, psychiatric disorders and any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology.

They will have to follow no chronic treatment and will have to be unhurt of any history of alcoholism or drug addiction.

Exclusion Criteria:

  • Usual contraindications for an examination MRI.

So, will not be included, the subjects:

  • suffering from claustrophobia,
  • having stimulating one cardiac, carriers of a system Holter,
  • carriers of hook(staple) (clip) surgical metallic,
  • Carriers of a prosthesis or a metallic implant (or quite different metallic foreign bodies),
  • carriers of a prosthesis dental (device),
  • carriers of a hearing aid,
  • carriers of an insulin pump,
  • having been hurt by pieces of shrapnel or lead,
  • Having had a dislocation, a fracture or a recent surgical operation (less than 6 months before the inclusion),
  • Having followed a treatment(processing) with anti-inflammatory drugs during the last 3 months, having followed a treatment(processing) with amino acids during 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Volunteer healthy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RMI
Time Frame: 36 months
Assessment of muscle function or brain
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 4, 2013

First Posted (ESTIMATE)

December 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-A01265-38
  • 2012-32 (OTHER: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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