Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04340999
Collaborator
(none)
56
1
19.1
2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

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.

Study Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Mar 5, 2020

Arms and Interventions

Arm Intervention/Treatment
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)
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

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)
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

Outcome Measures

Primary Outcome Measures

  1. Early detection of peripheral neuropathy among liver cirrhotic patients. [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit Giza Egypt

Sponsors and Collaborators

  • Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Reem Mahmoud Mohamed Ali Gabr, Resident of Clinical neurophysiology- Kasr alainy-Cairo University, Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT04340999
Other Study ID Numbers:
  • Electrophysiology - cirrhosis
First Posted:
Apr 10, 2020
Last Update Posted:
Apr 10, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Reem Mahmoud Mohamed Ali Gabr, Resident of Clinical neurophysiology- Kasr alainy-Cairo University, Kasr El Aini Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2020