PolyneuropathyNCT02566941

Neuromuscular Electrical Stimulation in the Critically Ill

A study testing Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation) in people with Polyneuropathy, run by Brugmann University Hospital at 1 site in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Polyneuropathy
What is being tested?: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteBelgium
Study dates: 1 Oct 2015to 30 May 2018
Phase: Interventional
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

Admission in the ICU of the Brugmann Hospital (Unit 1020) with an intended ICU stay superior to 3 days
Aged over 18 years
Respiratory assistance needed (invasive and non-invasive ventilation, CPAP or Optiflow and PaO2(arterial oxygen pressure)/FiO2(fraction of inhaled oxygen)<200mmHg)
SAPSII (Simplified Acute Physiology Score) between entre 35 et 70.

Who cannot join

Definitive exclusion criteria:
patients bearing a pacemaker or an AICD (automatic implantable cardioverter/defibrillator )
BMI superior to 35
serious neuromuscular pathologies or alterations in the inferior members that make both tights stimulation impossible
pregnant women
patients admitted from Friday evening to Sunday morning

Show all 12Show fewer

Temporary exclusion criteria:
Hemodynamic instability (even with filling up and amines: noradrenaline > 0.5y/kg/min and/or dobutamine >5y/kg/min and/or adrenaline ivc)
Extreme severity with suspicion of death within the first 24 h
PIC > 20 cmH2O
Severe agitation (RASS > +1)
Curare utilisation within the last 24h

Trial locations and contacts

1 site in 1 country.

Belgium1 site

CHU Brugmann
Brussels, 1020

Other trials in Belgium

About this study

Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of COPD (chronic obstructive pulmonary disease) patients (among others) to improve their resistance to efforts in everyday life. In patients in intensive care, it seems to improve strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days, with expected effects on the duration of hospitalization and the long-term functional outcome. Although its use could sometimes be limited by the development of peripheral edema and use of vasoconstrictors, the main advantage of this technique is the possibility of being used very early, even in patients that require deep sedation . This is extremely important given that the muscular atrophy process already starts 18h after the onset of invasive ventilation and as signs of impaired nerve transmission are developed in one third of patients at risk within 72 hours.

The purpose of the study is to assess the effects, in the short and medium term, of early neuromuscular stimulation in patients who are at higher risk of developing a critical illness polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.

This is a randomized controlled single-blind study comparing a group of patients submitted to NMES early (up to 5 days after admission) versus a control group unstimulated.

Conditions: Polyneuropathy
Being tested: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)
Keywords: critical illness polyneuropathy, critical illness myopathy, neuromuscular electrical stimulation, intensive care unit acquired weakness, prevention of critical illness polyneuropathy
Medical subject headings: Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)Device

Study groups in NCT02566941
Study group	Role	What they receive
Stimulated	Experimental	Patients included in the 'stimulated' group will be stimulated at the level of the quadriceps twice a day, bilaterally and simultaneously, five days per week from Monday to Friday (Stimulator: Gymna Belgium, DUO 400). The stimulation protocol (rectified alternating current; frequency, 75 Hz; intensity, 0-80 mA; pulse duration, 350 microseconds) is the one proposed by the manufacturer for atrophy prevention. The intensity of the electrical current will be gradually increased, without exceeding 80mA or the pain threshold of the patient. Receives: Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of respiratory support
The duration of ventilatory support is defined as the time in days, during which the patient requires invasive media type (continuous or not, intubation or tracheotomy and need the help of the respirator) or noninvasive (discontinuous or CPAP NIV (continuous positive airway pressure, noninvasive ventilation)- dependence). This will be assessed during the entire length of stay of the patient inside the intensive care unit (ICU).
Measured: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Length of stay in the intensive care unit
Measured in days
Measured: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Type of hospital discharge
Back to home or to a specialized long term care structure
Measured: At hospital discharge, within a maximum of two years (approximate study length).

Secondary outcomes (20)

cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Measured: First day in ICU
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Measured: Third day in ICU
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Measured: Fifth day in ICU
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Measured: Seventh day in ICU
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Measured: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Grip test
The "Grip Test" involves measuring the grip force developed by the hand of the patient, using a dynamometer (Neugen Medicals MODEL EH 101). This test will be conducted as soon as possible aka when the patient has -1 ≤ RASS ≤ 1, is sufficiently collaborating and little sedated.
Measured: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Grip test
The "Grip Test" involves measuring the grip force developed by the hand of the patient, using a dynamometer (Neugen Medicals MODEL EH 101). This test will be performed on the day the patient is discharged from the intensive care unit.
Measured: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Bike
The bike (Neugen Medicals MODEL EH 101) is a true "bike room" which facilitates active and passive mobilization of bedridden patients and allows, among other things, to measure the force developed by the patients and the ratio between active and passive labor work.This test will be conducted as soon as possible aka when the patient has -1 ≤ RASS ≤ 1, is sufficiently collaborating and little sedated.
Measured: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Bike
The bike (Neugen Medicals MODEL EH 101) is a true "bike room" which facilitates active and passive mobilization of bedridden patients and allows, among other things, to measure the force developed by the patients and the ratio between active and passive labor work.This will be measured at patient discharge from ICU
Measured: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Electromyogram
The Electrical conduction of nerves fibula will be assessed to detect nerve damage. A positive test will involve a complete electrophysiological monitoring by a specialist.
Measured: First day of ICU admission
Electromyogram
The Electrical conduction of nerves fibula will be assessed to detect nerve damage. A positive test will involve a complete electrophysiological monitoring by a specialist.
Measured: Third day of ICU admission
Electromyogram
The Electrical conduction of nerves fibula will be assessed to detect nerve damage. A positive test will involve a complete electrophysiological monitoring by a specialist.
Measured: Fifth day of ICU admission
Electromyogram
The Electrical conduction of nerves fibula will be assessed to detect nerve damage. A positive test will involve a complete electrophysiological monitoring by a specialist.
Measured: Seventh day of ICU admission
Electromyogram
The Electrical conduction of nerves fibula will be assessed to detect nerve damage. A positive test will involve a complete electrophysiological monitoring by a specialist.
Measured: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Physical Function ICU Test score (PFIT-s)
This simple functional test was developed to measure the functional abilities of patients severely debilitated that are found in the ICU. It consists in assessing four different levels of physical ability: the bending force of the shoulder and knee extension in sitting position, measured with the Oxford scale; the level of assistance needed to move from a sitting position to a standing position; and the ability to stand and walk on site. Patients will be tested as soon as possible aka when the patient has: -1 ≤ RASS ≤ 1, is sufficiently collaborating and not heavily sedated.
Measured: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Physical Function ICU Test score (PFIT-s)
This simple functional test was developed to measure the functional abilities of patients severely debilitated that are found in the ICU. It consists in assessing four different levels of physical ability: the bending force of the shoulder and knee extension in sitting position, measured with the Oxford scale; the level of assistance needed to move from a sitting position to a standing position; and the ability to stand and walk on site.
Measured: the day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Six minutes Walking Test
The 6-minute walk test is a validated and commonly used test to assess submaximal functional capacity; the test is conducted according to the guidelines of the American Thoracic Society.
Measured: the day the patient is discharged from the hospital, within a maximum of 2 years (approximate total study length)
Six minutes Walking Test
The 6-minute walk test is a validated and commonly used test to assess submaximal functional capacity; the test is conducted according to the guidelines of the American Thoracic Society.
Measured: one year after the day of admission to the intensive care unit
MOS SF-36
The MOS SF-36 questionnaire will be proposed to patients on the day of hospital discharge and one year after the day of admission to the ICU, to assess their quality of life.
Measured: the day the patient is discharged from the hospital, within a maximum of two years (approximated study lenght)
MOS SF-36
The MOS SF-36 questionnaire will be proposed to patients on the day of hospital discharge and one year after the day of admission to the ICU, to assess their quality of life.
Measured: one year after the day of admission to the intensive care unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201530 May 2018

First posted2 Oct 2015 (estimated)
Study start1 Oct 2015
Primary completion30 May 2018
Study completion30 May 2018

Why it stopped: Lack of human ressources

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for PolyneuropathyStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02566941
Sponsor's protocol ID: CHUB-SNM001
Status last verified: May 2018
First submitted: 14 Aug 2015
Last updated: 31 May 2018
Results posted: No
Data monitoring committee: No

Publications

Dal-Pizzol F, Ritter C. Functional disability 5 years after ARDS. N Engl J Med. 2011 Jul 21;365(3):274-5; author reply 275-6. doi: 10.1056/NEJMc1105509. No abstract available.
PubMed 21774725
Batt J, dos Santos CC, Cameron JI, Herridge MS. Intensive care unit-acquired weakness: clinical phenotypes and molecular mechanisms. Am J Respir Crit Care Med. 2013 Feb 1;187(3):238-46. doi: 10.1164/rccm.201205-0954SO. Epub 2012 Nov 29.
PubMed 23204256
Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Interventions for preventing critical illness polyneuropathy and critical illness myopathy. Cochrane Database Syst Rev. 2014 Jan 30;2014(1):CD006832. doi: 10.1002/14651858.CD006832.pub3.
PubMed 24477672
Maddocks M, Gao W, Higginson IJ, Wilcock A. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD009419. doi: 10.1002/14651858.CD009419.pub2.
PubMed 23440837
Dirks ML, Wall BT, Snijders T, Ottenbros CL, Verdijk LB, van Loon LJ. Neuromuscular electrical stimulation prevents muscle disuse atrophy during leg immobilization in humans. Acta Physiol (Oxf). 2014 Mar;210(3):628-41. doi: 10.1111/apha.12200. Epub 2013 Dec 12.
PubMed 24251881
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 20426834
Burke D, Gorman E, Stokes D, Lennon O. An evaluation of neuromuscular electrical stimulation in critical care using the ICF framework: a systematic review and meta-analysis. Clin Respir J. 2016 Jul;10(4):407-20. doi: 10.1111/crj.12234. Epub 2014 Nov 26.
PubMed 25353646
Hirose T, Shiozaki T, Shimizu K, Mouri T, Noguchi K, Ohnishi M, Shimazu T. The effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance in the intensive care unit. J Crit Care. 2013 Aug;28(4):536.e1-7. doi: 10.1016/j.jcrc.2013.02.010. Epub 2013 Apr 3.
PubMed 23561945
Segers J, Hermans G, Bruyninckx F, Meyfroidt G, Langer D, Gosselink R. Feasibility of neuromuscular electrical stimulation in critically ill patients. J Crit Care. 2014 Dec;29(6):1082-8. doi: 10.1016/j.jcrc.2014.06.024. Epub 2014 Jun 30.
PubMed 25108833
Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735
Latronico N, Bertolini G, Guarneri B, Botteri M, Peli E, Andreoletti S, Bera P, Luciani D, Nardella A, Vittorielli E, Simini B, Candiani A. Simplified electrophysiological evaluation of peripheral nerves in critically ill patients: the Italian multi-centre CRIMYNE study. Crit Care. 2007;11(1):R11. doi: 10.1186/cc5671.
PubMed 17254336
Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, Rafferty G, Polkey MI, Moxham J. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009 May;64(5):418-23. doi: 10.1136/thx.2008.103986. Epub 2009 Jan 21.
PubMed 19158125
Latronico N, Nattino G, Guarneri B, Fagoni N, Amantini A, Bertolini G; GiVITI Study Investigators. Validation of the peroneal nerve test to diagnose critical illness polyneuropathy and myopathy in the intensive care unit: the multicentre Italian CRIMYNE-2 diagnostic accuracy study. F1000Res. 2014 Jun 11;3:127. doi: 10.12688/f1000research.3933.3. eCollection 2014.
PubMed 25309729
Skinner EH, Berney S, Warrillow S, Denehy L. Development of a physical function outcome measure (PFIT) and a pilot exercise training protocol for use in intensive care. Crit Care Resusc. 2009 Jun;11(2):110-5.
PubMed 19485874
Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.
PubMed 23886842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuromuscular Electrical Stimulation in the Critically Ill
ClinicalTrials.gov ID: NCT02566941
Acronym / sponsor ID: CHUB-SNM001
Conditions: Polyneuropathy
Keywords: critical illness polyneuropathy, critical illness myopathy, neuromuscular electrical stimulation, intensive care unit acquired weakness, prevention of critical illness polyneuropathy
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of human ressources
Enrolment: 0 participants (actual)
Lead sponsor: Brugmann University HospitalUniversity, hospital or other
Study start: 1 Oct 2015 (actual)
Primary completion: 30 May 2018 (actual)
Study completion: 30 May 2018 (actual)
First posted: 2 Oct 2015 (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.

This is a randomized controlled single-blind study comparing a group of patients submitted to NMES early (up to 5 days after admission) versus a control group unstimulated.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Stimulated	Experimental	Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)Patients included in the 'stimulated' group will be stimulated at the level of the quadriceps twice a day, bilaterally and simultaneously, five days per week from Monday to Friday (Stimulator: Gymna Belgium, DUO 400). The stimulation protocol (rectified alternating current; frequency, 75 Hz; intensity, 0-80 mA; pulse duration, 350 microseconds) is the one proposed by the manufacturer for atrophy prevention. The intensity of the electrical current will be gradually increased, without exceeding 80mA or the pain threshold of the patient.
Control	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Admission in the ICU of the Brugmann Hospital (Unit 1020) with an intended ICU stay superior to 3 days
Aged over 18 years
Respiratory assistance needed (invasive and non-invasive ventilation, CPAP or Optiflow and PaO2(arterial oxygen pressure)/FiO2(fraction of inhaled oxygen)<200mmHg)
SAPSII (Simplified Acute Physiology Score) between entre 35 et 70.

Key exclusion criteria (12 listed)

patients bearing a pacemaker or an AICD (automatic implantable cardioverter/defibrillator )
BMI superior to 35
serious neuromuscular pathologies or alterations in the inferior members that make both tights stimulation impossible
pregnant women
patients admitted from Friday evening to Sunday morning

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
Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)	Device	Stimulated

Primary outcome

Duration of respiratory support
Time frame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
The duration of ventilatory support is defined as the time in days, during which the patient requires invasive media type (continuous or not, intubation or tracheotomy and need the help of the respirator) or noninvasive (discontinuous or CPAP NIV (continuous positive airway pressure, noninvasive ventilation)- dependence). This will be assessed during the entire length of stay of the patient inside the intensive care unit (ICU).
Length of stay in the intensive care unit
Time frame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Measured in days
Type of hospital discharge
Time frame: At hospital discharge, within a maximum of two years (approximate study length).
Back to home or to a specialized long term care structure

20 secondary outcomes

cross-sectional area of the rectus femoris
Time frame: First day in ICU
cross-sectional area of the rectus femoris
Time frame: Third day in ICU
cross-sectional area of the rectus femoris
Time frame: Fifth day in ICU
cross-sectional area of the rectus femoris
Time frame: Seventh day in ICU
cross-sectional area of the rectus femoris
Time frame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Grip test
Time frame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Grip test
Time frame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Bike
Time frame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Force index - Bike
Time frame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Electromyogram
Time frame: First day of ICU admission
Electromyogram
Time frame: Third day of ICU admission
Electromyogram
Time frame: Fifth day of ICU admission
Electromyogram
Time frame: Seventh day of ICU admission
Electromyogram
Time frame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Physical Function ICU Test score (PFIT-s)
Time frame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Physical Function ICU Test score (PFIT-s)
Time frame: the day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Six minutes Walking Test
Time frame: the day the patient is discharged from the hospital, within a maximum of 2 years (approximate total study length)
Six minutes Walking Test
Time frame: one year after the day of admission to the intensive care unit
MOS SF-36
Time frame: the day the patient is discharged from the hospital, within a maximum of two years (approximated study lenght)
MOS SF-36
Time frame: one year after the day of admission to the intensive care unit

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
Background: PubMed 21774725Dal-Pizzol F, Ritter C. Functional disability 5 years after ARDS. N Engl J Med. 2011 Jul 21;365(3):274-5; author reply 275-6. doi: 10.1056/NEJMc1105509. No abstract available.
Background: PubMed 23204256Batt J, dos Santos CC, Cameron JI, Herridge MS. Intensive care unit-acquired weakness: clinical phenotypes and molecular mechanisms. Am J Respir Crit Care Med. 2013 Feb 1;187(3):238-46. doi: 10.1164/rccm.201205-0954SO. Epub 2012 Nov 29.
Background: PubMed 24477672Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Interventions for preventing critical illness polyneuropathy and critical illness myopathy. Cochrane Database Syst Rev. 2014 Jan 30;2014(1):CD006832. doi: 10.1002/14651858.CD006832.pub3.
Background: PubMed 23440837Maddocks M, Gao W, Higginson IJ, Wilcock A. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD009419. doi: 10.1002/14651858.CD009419.pub2.
Background: PubMed 24251881Dirks ML, Wall BT, Snijders T, Ottenbros CL, Verdijk LB, van Loon LJ. Neuromuscular electrical stimulation prevents muscle disuse atrophy during leg immobilization in humans. Acta Physiol (Oxf). 2014 Mar;210(3):628-41. doi: 10.1111/apha.12200. Epub 2013 Dec 12.
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 25353646Burke D, Gorman E, Stokes D, Lennon O. An evaluation of neuromuscular electrical stimulation in critical care using the ICF framework: a systematic review and meta-analysis. Clin Respir J. 2016 Jul;10(4):407-20. doi: 10.1111/crj.12234. Epub 2014 Nov 26.
Background: PubMed 23561945Hirose T, Shiozaki T, Shimizu K, Mouri T, Noguchi K, Ohnishi M, Shimazu T. The effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance in the intensive care unit. J Crit Care. 2013 Aug;28(4):536.e1-7. doi: 10.1016/j.jcrc.2013.02.010. Epub 2013 Apr 3.
Background: PubMed 25108833Segers J, Hermans G, Bruyninckx F, Meyfroidt G, Langer D, Gosselink R. Feasibility of neuromuscular electrical stimulation in critically ill patients. J Crit Care. 2014 Dec;29(6):1082-8. doi: 10.1016/j.jcrc.2014.06.024. Epub 2014 Jun 30.
Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
Background: PubMed 17254336Latronico N, Bertolini G, Guarneri B, Botteri M, Peli E, Andreoletti S, Bera P, Luciani D, Nardella A, Vittorielli E, Simini B, Candiani A. Simplified electrophysiological evaluation of peripheral nerves in critically ill patients: the Italian multi-centre CRIMYNE study. Crit Care. 2007;11(1):R11. doi: 10.1186/cc5671.
Background: PubMed 19158125Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, Rafferty G, Polkey MI, Moxham J. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009 May;64(5):418-23. doi: 10.1136/thx.2008.103986. Epub 2009 Jan 21.

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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.

Jacques Devriendt, MD principal investigator

CHU Brugmann

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation) in people with Polyneuropathy, run by Brugmann University Hospital at 1 site in Belgium.

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 12 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: withdrawn, as of the sponsor's last update on 31 May 2018. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of respiratory support (time frame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.). The study lists 3 primary outcomes in all. 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 NCT02566941, which also lists 16 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 31 May 2018.