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NMES in Critically Ill Patients

Neuromuscular Electrical Stimulation in Critically Ill Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02133300
Acronym
NESCI
Enrollment
50
Registered
2014-05-08
Start date
2014-05-31
Completion date
2017-10-31
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients With a Predicted Prolonged ICU Stay

Brief summary

Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.

Interventions

OTHERelectrical stimulation

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* All adult ICU patients with a predicted prolonged ICU stay

Exclusion criteria

* Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, …) * Receiving neuromuscular blocking agents * Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease ) * Focal neurological conditions of the pelvis and/or lower limb * Skin disease (e.g. burns) * Presence of a pace-maker or defibrillator * Hemodynamic or Respiratory Instability, active cardiac ischemia * High fever (\>39°) * Pregnancy * Brain death * Intracranial pressure \>20 mmHg * An anticipated fatal outcome * Psychiatric disorders or severe agitation * Re-admission to the ICU

Design outcomes

Primary

MeasureTime frameDescription
Muscle thicknesspre-intervention periodUltrasound measure in cm

Secondary

MeasureTime frameDescription
Muscle strength (MRC & HHD)pre intervention periodMRC: scale HHD: MicroFet, in kg Force
Muscle fiber thicknesspost intervention periodbiopsy using Bergström-Stille 5mm needles
Protein balancepost interventionbiopsy using Bergström-Stille 5mm needles

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026