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Clinical Trials/NCT04340999
NCT04340999
Completed
Not Applicable

Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

Kasr El Aini Hospital1 site in 1 country56 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhoses
Sponsor
Kasr El Aini Hospital
Enrollment
56
Locations
1
Primary Endpoint
Early detection of peripheral neuropathy among liver cirrhotic patients.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
March 5, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kasr El Aini Hospital
Responsible Party
Principal Investigator
Principal Investigator

Reem Mahmoud Mohamed Ali Gabr

Resident of Clinical neurophysiology- Kasr alainy-Cairo University

Kasr El Aini Hospital

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).

Outcomes

Primary Outcomes

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

  • Detection of correlation between neuropathy and severity of liver cirrhosis.(baseline)
  • Motor unit number estimation using Spike-Triggered method.(Baseline)
  • Correlation of MUNE values to fatigue(Baseline)

Study Sites (1)

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