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

Sponsor

Adana City Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04227548

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Polyneuromyopathy	Diagnostic Test: needle electromyography	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 30, 2019

Actual Primary Completion Date :

Dec 2, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy individuals	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.

Arm

Intervention/Treatment

Experimental: Healthy individuals

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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adana City Training and Research Hospital	Adana		Turkey	01230

Sponsors and Collaborators

Adana City Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halit Fidancı, Medical Doctor, Neurology and Clinical Neurophysiology, Adana City Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04227548

Other Study ID Numbers:

30/401

First Posted:

Jan 13, 2020

Last Update Posted:

Jan 13, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Halit Fidancı, Medical Doctor, Neurology and Clinical Neurophysiology, Adana City Training and Research Hospital

Critical illness myopathy

Critical illness neuropathy

direct muscle stimulation

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Jan 13, 2020