NCT02001675

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 5, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

December 21, 2012

Last Update Submit

December 4, 2013

Conditions

Keywords

Neuromuscular electrical stimulation (NMES)

Outcome Measures

Primary Outcomes (1)

  • RMI

    Assessment of muscle function or brain

    36 months

Study Arms (1)

Volunteer healthy

EXPERIMENTAL
Device: magnetic resonance imaging (MRI)Device: 31-phosphorous magnetic resonance spectroscopy (MRS-P31)

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 followed a treatment(processing) with anti-inflammatory drugs during the last 3 months, having followed a treatment(processing) with amino acids during 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • michele DAMON

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2012

First Posted

December 5, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

December 5, 2013

Record last verified: 2013-11

Locations