Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation

Not Applicable

Completed

• Conditions: Critical Illness Polyneuromyopathy
• Interventions: Diagnostic Test: needle electromyography

• Registration Number: NCT04227548
• Lead Sponsor: Adana City Training and Research Hospital

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.

Study Timeline

• Study Start: 2019-04-30
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy individuals	needle electromyography	-

Primary Outcome Measures

Name	Time	Method
the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation	1 hour	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)

Trial Locations

Locations (1)

Adana City Training and Research Hospital; 🇹🇷 Adana, Turkey