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Liver CirrhosesNCT04340999

Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

An observational study of Liver Cirrhoses and Peripheral Neuropathy, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Liver Cirrhoses, Peripheral Neuropathy
What is being tested?
Nerve conduction studies and Quantitative EMG ( MUNE and IPA)
How many people
56 participants
Where
1 siteEgypt
Study dates
1 Aug 2018to 5 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kasr Alainy Teaching Hospital-Clinical Neurophysiology Unit

    Giza

Other trials in Egypt

About this study

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

Read the 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.

Being tested
Nerve conduction studies and Quantitative EMG ( MUNE and IPA)
Keywords
Liver cirrhotic patients- Motor Dysfunction-Fatigue.
Medical subject headings
Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve conduction studies and Quantitative EMG ( MUNE and IPA)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

Study groups in NCT04340999
Study groupRoleWhat they receive
Manifested GroupManifested Group , enrolled patients who had any of the following manifestations(Fatigue,muscle cramps or numbness)
Receives: Diagnostic Test: Nerve conduction studies and Quantitative EMG ( MUNE and IPA)
Non-Manifested GroupNon-manifested group in which enrolled patients didn't report any of the following manifestations
Receives: Diagnostic Test: Nerve conduction studies and Quantitative EMG ( MUNE and IPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early detection of peripheral neuropathy among liver cirrhotic patients.

    • 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).

    Measured: baseline

Secondary outcomes (3)

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

    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.

    Measured: baseline

  2. Motor unit number estimation using Spike-Triggered method.

    • 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.

    Measured: Baseline

  3. Correlation of MUNE values to fatigue

    • 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2020
  2. Study start1 Aug 2018
  3. Primary completion31 Dec 2019
  4. Study completion5 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04340999
Sponsor's protocol ID
Electrophysiology - cirrhosis
Status last verified
Apr 2020
First submitted
4 Apr 2020
Last updated
10 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhoses and Peripheral Neuropathy, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early detection of peripheral neuropathy among liver cirrhotic patients. (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04340999, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.

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