Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy
2 other identifiers
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Dec 2012
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 21, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 5, 2013
November 1, 2013
3 years
December 21, 2012
December 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RMI
Assessment of muscle function or brain
36 months
Study Arms (1)
Volunteer healthy
EXPERIMENTALInterventions
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
michele DAMON
Assistance Publique Hopitaux De Marseille
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