Polyneuropathy, Critical IllnessPhase 3ENSNCT02706587
Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment
A Phase 3 study testing Neuromuscular electrical stimulation in people with Polyneuropathy, Critical Illness, run by Institut Mutualiste Montsouris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathy, Critical Illness
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient
- Aged of 18 or more
- With an intended ICU stay of at least 72 hours
- Mechanically ventilated
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Insitut Mutualiste Montsouris
Paris, 75014
Christian LAMER, +33156616188, christian.lamer@imm.fr
About this study
Official title: Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
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.
Read the detailed description
Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.
- Conditions
- Polyneuropathy, Critical Illness
- Being tested
- Neuromuscular electrical stimulation, Sham control
- Keywords
- Critical illness polyneuropathy, Neuromuscular Electrical Stimulation
- Medical subject headings
- Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
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 controlDevice
No electrostimulation
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | 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. Receives: Device: Neuromuscular electrical stimulation |
| Sham Control | Sham comparator | No electrostimulation Receives: Device: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical resuscitation council (MRC) score
Measured: up to 25 months. From date of randomization to the date of ICU discharge
Secondary outcomes (3)
Total duration of mechanical ventilation (days)
Measured: up to 25 months. From date of randomization to the date of ICU discharge
Length of ICU stay and hospital stay.
Measured: up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge
Type of hospital discharge
(alive/deceased/rehabilitation/home...)
Measured: up to 25 months. From date of randomization to the date of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polyneuropathy, Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Paul Bennetot, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Christian Lamer, MD, Principal investigator, Institut Mutualiste Montsouris, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706587
- Sponsor's protocol ID
- REA 01-2014
- Acronym
- ENS
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.
PubMed 20426834Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
PubMed 24758618Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.
PubMed 20046132Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.
PubMed 22421734
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
- ClinicalTrials.gov ID
- NCT02706587
- Acronym / sponsor ID
- ENS / REA 01-2014
- Conditions
- Polyneuropathy, Critical Illness
- Keywords
- Critical illness polyneuropathy, Neuromuscular Electrical Stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Fondation Paul Bennetot, Assistance Publique - Hôpitaux de Paris
- Study start
- Mar 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Device: Neuromuscular electrical stimulationNEMS 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 Control | Sham comparator | Device: Sham controlNo electrostimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patient
- Aged of 18 or more
- With an intended ICU stay of at least 72 hours
- Mechanically ventilated
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationNEMS 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 |
| Sham controlNo electrostimulation | Device | Sham Control |
Primary outcome
Medical resuscitation council (MRC) score
Time frame: up to 25 months. From date of randomization to the date of ICU discharge
3 secondary outcomes
Total duration of mechanical ventilation (days)
Time frame: up to 25 months. From date of randomization to the date of ICU discharge
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
Type of hospital discharge
Time frame: up to 25 months. From date of randomization to the date of hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 20426834Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.
- Background: PubMed 24758618Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
- Background: PubMed 20046132Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.
- Background: PubMed 22421734Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Lamer, MD principal investigator
Institut Mutualiste Montsouris, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuromuscular electrical stimulation in people with Polyneuropathy, Critical Illness, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Lamer, MD (+33156616188, christian.lamer@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical resuscitation council (MRC) score (time frame: up to 25 months. From date of randomization to the date of ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706587, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.