Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation
Primary Purpose
Critical Illness Polyneuromyopathy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
needle electromyography
Sponsored by
About this trial
This is an interventional diagnostic trial for Critical Illness Polyneuromyopathy focused on measuring Critical illness myopathy, Critical illness neuropathy, direct muscle stimulation
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals
Exclusion Criteria:
- Polyneuropathy
- a disease such as diabetes mellitus that causes polyneuropathy
- complaints such as weakness or paresthesia
- a neurodegenerative disease
- abnormal neurological examination
Sites / Locations
- Adana City Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy individuals
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04227548
First Posted
January 9, 2020
Last Updated
January 10, 2020
Sponsor
Adana City Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04227548
Brief Title
Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation
Official Title
Reference Values for the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adana City Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Age, gender, height, weight, body mass index and neurological examination findings of the participants were recorded. Healthy participants were not included if they had; polyneuropathy or a disease such as diabetes mellitus that causes polyneuropathy, complaints such as weakness or paresthesia, a neurodegenerative disease, abnormal neurological examination, myopathy or hereditary polyneuropathy in family history. In addition, healthy participants were excluded if the conventional nerve conduction study and needle electromyography (EMG) findings were abnormal. Median, ulnar, posterior tibial, peroneal, superficial peroneal, sural nerve conduction studies were performed to all participants. Needle EMG and direct muscle stimulation were applied to the deltoid and tibialis anterior muscles of the healthy participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness Polyneuromyopathy
Keywords
Critical illness myopathy, Critical illness neuropathy, direct muscle stimulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy individuals
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
needle electromyography
Intervention Description
Direct muscle stimulation was performed to deltoid and tibialis anterior muscles with a monopolar needle electrode. Recording was made with a concentric needle electrode.
Primary Outcome Measure Information:
Title
the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation
Description
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)
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals
Exclusion Criteria:
Polyneuropathy
a disease such as diabetes mellitus that causes polyneuropathy
complaints such as weakness or paresthesia
a neurodegenerative disease
abnormal neurological examination
Facility Information:
Facility Name
Adana City Training and Research Hospital
City
Adana
ZIP/Postal Code
01230
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation
We'll reach out to this number within 24 hrs