NCT04227548

Brief Summary

Direct muscle stimulation (DMS) method is one of the electrodiagnostic methods used in the diagnosis of critical illness myopathy (CIM) and critical illness neuropathy (CIN). The ratio of amplitude of compound muscle action potential (CMAP) obtained by nerve stimulation (nCMAP) to amplitude of CMAP obtained by DMS (dmCMAP) can be used to differentiate these two diseases. Although not certain, if the ratio is \< 0.5, the diagnosis is thought to be consistent with CIN. The ratio \> 0.5 is considered to be a finding supporting CIM. The investigators aimed to find the reference values of the ratio from healthy individuals. A monopolar needle electrode was used for DMS. The dmCMAP and nCMAP were recorded with a concentric needle. The ratio was calculated by using amplitudes of dmCMAP and nCMAP obtained from deltoid and tibialis anterior muscles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 9, 2020

Last Update Submit

January 10, 2020

Conditions

Keywords

Critical illness myopathyCritical illness neuropathydirect muscle stimulation

Outcome Measures

Primary Outcomes (1)

  • the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation

    The normal limits of the ratio were the primary outcome criteria. This ratio is high in critical illness myopathy or healthy individuals, while low in ciritical illness neuropathy of broken disease occurs. Considering the study of Lefaucheur et al., at least 23 healthy individuals should be included in the study.(Lefaucheur JP, Nordine T, Rodriguez P, Brochard L (2006) Origin of ICU acquired paresis determined by direct muscle stimulation. J Neurol Neurosurg Psychiatry 77:500-6)

    1 hour

Study Arms (1)

Healthy individuals

EXPERIMENTAL
Diagnostic Test: needle electromyography

Interventions

Direct muscle stimulation was performed to deltoid and tibialis anterior muscles with a monopolar needle electrode. Recording was made with a concentric needle electrode.

Healthy individuals

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals

You may not qualify if:

  • Polyneuropathy
  • a disease such as diabetes mellitus that causes polyneuropathy
  • complaints such as weakness or paresthesia
  • a neurodegenerative disease
  • abnormal neurological examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, 01230, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Neurology and Clinical Neurophysiology

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

April 30, 2019

Primary Completion

December 2, 2019

Study Completion

December 30, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations