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Completed

NCT Number: NCT04340999

Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

cross sectional observational study, aimed to assess the electrophysiological function of the motor units in liver cirrhotic patients.

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Key information

Conditions

Liver Cirrhoses Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peripheral Neuropathy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit

Giza, Egypt

About this study

Liver cirrhosis is a global health problem which could be associated with several neurological manifestations. The associated peripheral neuropathy could be assessed by conventional nerve conduction studies.

Objective: The study aims at early detection of peripheral neuropathy among patients of liver cirrhosis by conventional nerve conduction studies and quantitative EMG methods. In addition, the study aims at finding out correlation between peripheral neuropathy and severity of the liver cirrhosis.

Methods: This a cross-sectional study conducted on fifty-six liver cirrhotic patients, that had been recruited from the Endemic medicine department/outpatient clinics and their age-gender matched sixty-one healthy controls. The recruited patients were clinically assessed .Both conventional nerve conduction studies and quantitative EMG techniques in the form of MUNE calculation, using modified spike -triggered technique and IPA ratio evaluation were performed for the allocated cirrhotic patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders.
  • Age interval range between 18 and 60 years (To avoid maturational changes and aging process on motor unit number).
  • Liver cirrhotic patients( including compensated and decompensated patients);
  • Presenting hematemesis/melena and/or ascites.
  • Diagnosis of liver cirrhosis is confirmed by abdominal ultrasound

Exclusion criteria

  • Patients with identifiable cause of peripheral neuropathy (e.g. diabetic patients) .
  • Patients who developed hepatocellular carcinoma (to avoid para-neoplastic syndrome e.g. peripheral neuropathy)
  • Patients with other non-hepatic chronic illness such as: patients with renal disease (to avoid other causes of metabolic neuropathies).

Treatment and study plan

Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

Diagnostic Test

Nerve Conduction Studies: Electrophysiological method that tests the presence/absence of peripheral neuropathy.

MUNE: Electrophysiological technique that assess number of motor units. IPA: Electrophysiological method that assess interference pattern and hence, borderline cases of neuropathy/ myopathy

Primary outcomes

  1. Early detection of peripheral neuropathy among liver cirrhotic patients.

    Time frame: baseline

    • Using nerve conduction studies of the: left ulnar,left posterior tibial and right deep peroneal motor nerves;assess their distal latency (measured in milliseconds) ,amplitude (measured in millivolts) and conduction velocities (measured in m/s).In addition , to sensory studies of the left ulnar and right sural sensory nerves; assessment of peak latency (measured in milliseconds) , amplitude (measured in microvolts) and their conduction velocities(measured in m/s) .
    • Compare the values with our normative values.
    • Detect evidence of peripheral neuropathy ( increased in distal latency above the upper limit of its normal value, decreased conduction velocity below the lower limit of its normal value and decreased amplitude below lower limit of its normal value).
    • A minimum of three variables in two or more nerves are required to diagnose polyneuropathy as referenced by (Meulstee & Van Der Meche , 1995).

Secondary outcomes

  1. Detection of correlation between neuropathy and severity of liver cirrhosis.

    Time frame: baseline

    Finding out any correlation between peripheral neuropathy and severity of liver cirrhosis:

    • Comparing between patients with evidence of peripheral neuropathy (as detected by nerve conduction studies) and those without evidence of peripheral neuropathy versus the severity of their liver disease ( as assessed by Child-Pugh class) using Mann Whitney U test; to find out if their is statistical difference between them or not; denoting the presence/absence of correlation between peripheral neuropathy and the severity of the liver disease.

  2. Motor unit number estimation using Spike-Triggered method.

    Time frame: Baseline

    • Estimation of motor unit number using Spike-Triggered method in liver cirrhotic patients and age/gender healthy controls to find out of there is statistical difference between them.
    • Decline in MUNE values denotes loss of motor neurons.

  3. Correlation of MUNE values to fatigue

    Time frame: Baseline

    • Comparing between liver cirrhotic patients who reported fatigue(as part of their neurological symptoms) versus those who didn't report fatigue, regarding their MUNE values; using Mann Whitney U test.
    • If there is statistical difference between them; there would be correlation between loss of motor units and fatigue reported by the patients(this assumption was based on (Heckman & Enoka, 2012) &(Mota et al., 2020) conclusions that there is positive correlation between fatigability and loss of motor units.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 10, 2020
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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