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CompletedNCT04340999Updated Apr 10, 2020

Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

An observational study in Liver Cirrhoses and Peripheral Neuropathy, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-10.

Sponsored by Kasr El Aini Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Liver Cirrhoses
  • Peripheral Neuropathy

Keywords

  • Liver cirrhotic patients- Motor Dysfunction-Fatigue.
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In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 56 is below the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Fifty-Six liver cirrhotic patients that were recruited from the Endemic medicine department and its outpatient clinics, at Kasr Alainy hospitals, Cairo University.

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

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).
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
56 participants (actual)
Patient registry
No

Groups and cohorts

  • Manifested Group

    Manifested Group , enrolled patients who had any of the following manifestations(Fatigue,muscle cramps or numbness)

    Diagnostic Test: Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

  • Non-Manifested Group

    Non-manifested group in which enrolled patients didn't report any of the following manifestations

    Diagnostic Test: Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

Interventions

  • Diagnostic testNerve conduction studies and Quantitative EMG ( MUNE and IPA)

    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

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What researchers measure

Primary outcomes

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

    * 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).

    Time frame: baseline

Secondary outcomes

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

    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.

    Time frame: baseline

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

    * 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.

    Time frame: Baseline

  3. Correlation of MUNE values to fatigue

    * 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.

    Time frame: Baseline

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Study locations

1 site
  • Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit
    Giza, Egypt
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References and documents

Publications

  • • Abdel-Razek, W., Hassany, M., Kabil, K., Ammar, I., Dabous, H., Doss, W., ... & El-Serafy, M. (2019). The World's Largest Hepatitis C Screening Program in Egypt. Journal of Hepatology (Vol. 70, pp. 144-145). • Abrams, G. A., Concato, J., & Fallon, M. B. (1996). Muscle cramps in patients with cirrhosis. American Journal of Gastroenterology, 91(7). • Aggarwal A, Nicholson G. (2002).Detection of preclinical motor neurone loss in SOD1 mutation carriers using motor unit number estimation. Journal of Neurology, Neurosurgery & Psychiatry; 73(2):199-201. • Amodio, P., & Gatta, A. (2005). Neurophysiological investigation of hepatic encephalopathy. Metabolic brain disease, 20(4), 369-379. • Arabadzhiev, T. I., Dimitrov, G. V., Dimitrov, A. G., Chakarov, V. E., & Dimitrova, N. A. (2008). Factors affecting the turns analysis of the interference EMG signal. Biomedical Signal Processing and Control, 3(2), 145-153. • Barkhaus, P. E. (2001). Motor Unit Action Potential Quantitation. In An AAEM workshop. Rochester, Minn: American Association of Electrodiagnostic Medicine (Vol. 2). • Bessou, P., Emonet-Dénand, F., & Laporte, Y. (1965). Motor fibres innervating extrafusal and intrafusal muscle fibres in the cat. The Journal of Physiology, 180(3), 649-672. • Blok, J. H., van Dijk, J. P., Drost, G., Zwarts, M. J., & Stegeman, D. F. (2002). A high-density multichannel surface electromyography system for the characterization of single motor units. Review of Scientific Instruments, 73(4), 1887-1897.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04340999
Lead sponsor
Kasr El Aini Hospital
Responsible party
Reem Mahmoud Mohamed Ali Gabr (Resident of Clinical neurophysiology- Kasr alainy-Cairo University, Kasr El Aini Hospital) — Principal investigator
First posted
Apr 10, 2020
Start date
Aug 1, 2018
Primary completion
Dec 31, 2019
Completion
Mar 5, 2020
Last update
Apr 10, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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