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

Critical Illness Polyneuromyopathy Clinical Trial

Official title:

Reference Values for the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227548
• Other study ID #: 30/401
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Adana City Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 30, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Polyneuromyopathy

Intervention

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

Locations

Country	Name	City	State
Turkey	Adana City Training and Research Hospital	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Adana City Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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