The ELMS Trial: ELectrical and Magnetic Stimulation to mitigate Intensive Care Unit-acquired weakness after trauma

• Register: ISRCTN
• Last refreshed on: 30 March 2020
• Main ID: ISRCTN12562519
• Date of registration: 19/09/2013
• Prospective Registration: Yes
• Primary sponsor: University of Birmingham (UK)
• Public title: The ELMS Trial: ELectrical and Magnetic Stimulation to mitigate Intensive Care Unit-acquired weakness after trauma
• Scientific title: A pilot randomised controlled trial of electrical and magnetic stimulation against sham to mitigate intensive-care-unit-acquired weakness after trauma
• Date of first enrolment: 01/10/2013
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12562519
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Prevention, Treatment (Prevention)
• Phase: Phase II

Countries of recruitment

United Kingdom

Contacts

• Name: Iain Smith

Key inclusion & exclusion criteria

Inclusion criteria:
Patients must:
1. be aged 16 years old or over
2. have been able to transfer independently from bed to chair prior to injury
3. be admitted to the Critical Care Unit at Queen Elizabeth Hospital, Birmingham as result of traumatic injury
4. have an anticipated length of stay of at least 2 weeks
5. give consent (or, if lacking capacity at screening, have a personal or professional consultee indicate that they would be likely to give consent were they not lacking capacity)
Target Gender: Male & Female

Exclusion criteria:
Patients must not:
1. refuse to allow their GP to be informed of participation
2. have known systemic neuromuscular disease (e.g. Guillain Barré Syndrome) at ICU admission
3. have known pathology affecting the brain, causing weakness (e.g. stroke or bleeding in the brain) at the time of Critical Care Unit admission
4. have any pacemaker (e.g., cardiac, diaphragm, gastric) or implanted cardiac defibrillator, neurostimulator, intracardiac line or cochlear implant
5. have any metallic implants or foreign bodies in the areas to be stimulated
6. have any metal (other than titanium) in the head or brain
7. have known or suspected malignancy in any limb
8. be pregnant
9. have a body mass index =35 kg/m2
10. have been an critical care patient for more than 7 days prior to enrolment
11. be moribund (i.e. >90% probability of patient mortality in the next 96 hours)
12. have any limitation in life support at the time of enrolment other than an instruction not to attempt cardiopulmonary resuscitation in the event of cardiac arrest
13. have upper limb fractures


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

ICU-acquired weakness
Musculoskeletal Diseases
Muscle wasting and atrophy, not elsewhere classified

Intervention(s)

1. Electrical stimulation: bilateral transcutaneous electrical stimulation of upper limb muscles for one hour daily for 10 days
2. Magnetic stimulation, 45 minutes of stimulation to each upper limb for 10 days
3. Sham electrical stimulation: simulated bilateral upper limb electrical stimulation for one hour daily for 10 days
4. Sham magnetic stimulation: 45 minutes of apparent stimulation per day for 10 days, with an intensity below that required to cause muscle contraction

Primary Outcome(s)

Incidence of ICU-Acquired Weakness
Timepoint(s): Day after completion of intervention regimen or at first point where participant can be assessed

Secondary Outcome(s)

1. Critical Care Unit and Hospital length of stay; Timepoint(s): At discharge from CCU and hospital
2. Grip strength and MRC Sumscale of upper limb muscles; Timepoint(s): Day after completion of intervention or earliest point at which participant can be assessed
3. Inflammatory profile during intervention; Timepoint(s): Day 0, 3, 6 and 10
4. Interval to independent mobilisation; Timepoint(s): during hospital stay
5. Interval to independent transfer from bed to chair; Timepoint(s): During hospital stay
6. Muscle architecture; Timepoint(s): Biceps biopsy taken on day after completion of stimulation
7. Nerve conduction studies; Timepoint(s): Day after completion of stimulation regimen
8. Northwick Park Dependency Score; Timepoint(s): Hospital discharge
9. Quality of Life; Timepoint(s): Hospital discharge and 6 months post- discharge

Secondary ID(s)

15027

Source(s) of Monetary Support

NIHR Surgical Reconstruction & Microbiology Research Centre, UK

Ethics review

Status:
Approval date:
Contact:

Medical Research Ethic Committee (MREC); Approval date 28/08/2013; Ref: 13/YH/0246

Results

• Results available: Yes
• Date Completed: 01/04/2014