- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340999
Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giza, Egypt
- Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Manifested Group
Manifested Group , enrolled patients who had any of the following manifestations(Fatigue,muscle cramps or numbness)
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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
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early detection of peripheral neuropathy among liver cirrhotic patients.
Time Frame: baseline
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Detection of correlation between neuropathy and severity of liver cirrhosis.
Time Frame: baseline
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Finding out any correlation between peripheral neuropathy and severity of liver cirrhosis:
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baseline
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Motor unit number estimation using Spike-Triggered method.
Time Frame: Baseline
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Baseline
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Correlation of MUNE values to fatigue
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Electrophysiology - cirrhosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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