Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

NCT ID: NCT04340999

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-03-05

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.

Conditions

Liver Cirrhoses; Peripheral Neuropathy

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Manifested Group

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

Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

Intervention Type: DIAGNOSTIC_TEST

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

Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Reem Mahmoud Mohamed Ali Gabr

Resident of Clinical neurophysiology- Kasr alainy-Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit

Giza, , Egypt

Countries

Egypt

References

• 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.

Reference Type: BACKGROUND

Other Identifiers

Electrophysiology - cirrhosis

Identifier Type: -

Identifier Source: org_study_id