Clinical trial NCT04340999: Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients
Official title: Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhoses
Peripheral Neuropathy
Keywords: Liver cirrhotic patients- Motor Dysfunction-Fatigue.
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Early detection of peripheral neuropathy among liver cirrhotic patients.
timeFrame: baseline
Secondary outcomes:
measure: Detection of correlation between neuropathy and severity of liver cirrhosis.
timeFrame: baseline
measure: Motor unit number estimation using Spike-Triggered method.
timeFrame: Baseline
measure: Correlation of MUNE values to fatigue
timeFrame: Baseline
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit
Study officials:
References:
citation: • 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.