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Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment (ENS)

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ClinicalTrials.gov Identifier: NCT02706587
Recruitment Status : Unknown
Verified September 2016 by Institut Mutualiste Montsouris.
Recruitment status was:  Recruiting
First Posted : March 11, 2016
Last Update Posted : September 13, 2016
Sponsor:
Collaborators:
Fondation Paul Bennetot
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Brief Summary:
The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

Condition or disease Intervention/treatment Phase
Polyneuropathy, Critical Illness Device: Neuromuscular electrical stimulation Device: Sham control Phase 3

Detailed Description:
Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Neuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
Device: Neuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.

Sham Comparator: Sham Control
No electrostimulation
Device: Sham control
No electrostimulation




Primary Outcome Measures :
  1. Medical resuscitation council (MRC) score [ Time Frame: up to 25 months. From date of randomization to the date of ICU discharge ]

Secondary Outcome Measures :
  1. Total duration of mechanical ventilation (days) [ Time Frame: up to 25 months. From date of randomization to the date of ICU discharge ]
  2. Length of ICU stay and hospital stay. [ Time Frame: up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge ]
  3. Type of hospital discharge [ Time Frame: up to 25 months. From date of randomization to the date of hospital discharge ]
    (alive/deceased/rehabilitation/home...)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patient
  • Aged of 18 or more
  • With an intended ICU stay of at least 72 hours
  • Mechanically ventilated

Exclusion Criteria:

  • Age less than 18 years
  • Pregnant women
  • Preexisting neuromuscular disease
  • Patient bearing a pace maker or an implantable defibrillator.
  • Poly traumatism and/or leg fracture.
  • End stage disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706587


Contacts
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Contact: Christian Lamer, MD +33156616188 christian.lamer@imm.fr
Contact: Celine Menez, PT +33156616134 celine.menez@imm.fr

Locations
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France
Insitut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: Christian LAMER    +33156616188    christian.lamer@imm.fr   
Sponsors and Collaborators
Institut Mutualiste Montsouris
Fondation Paul Bennetot
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christian Lamer, MD Institut Mutualiste Montsouris, Paris, France
Publications:
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Responsible Party: Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT02706587    
Other Study ID Numbers: REA 01-2014
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Mutualiste Montsouris:
Critical illness polyneuropathy
Neuromuscular Electrical Stimulation
Additional relevant MeSH terms:
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Polyneuropathies
Critical Illness
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases