Preliminary Registration Detail

Research Registry No : PLRID-00527_V5
Postgraduate Research : No
University Departmental Research : Yes
Name of University : University of Medicine 1, Yangon
Department : Department of Neurology
Registration Date : 2020-02-03
Principle Investigator : WIN MIN THIT
Title of Research : Reference values for nerve conduction among normal healthy subjects in Myanmar
Field of Research : Neurology
Preliminary Research Design : Descriptive Study
Preliminary Research Type : Applied
Preliminary Justification : Nerve conduction study (NCS) plays an essential role in assessing the diagnosis, severity, progress and outcome of various types of neuropathies including mononeuropathies, peripheral neuropathies, plexopathies and radiculopathies. Basically, to decide normal or abnormal, it is essential to compare with reference values of normal healthy subjects because previous studies have reported differences in values related to ethnicity and dermographic factors. Various neurological laboratories in various countries use their own reference data to compare. However, in Myanmar, reference values for nerve conduction study among normal healthy subjects has not been studied yet and currently, hospitals in Myanmar are using normal reference values of Europeans from textbooks and values of other countries’ data such as Singapore and India. However, NCS parameters are known to vary with demographic profile. Therefore, there is an urgent need to conduct the normal values of NCS parameters in Myanmar population. So the present study is designed to study the normal reference values for nerve conduction studies among Myanmar people. This study will be a fundamental research in establishing reference values of nerve conduction parameters in Myanmar as study area will be two main tertiary centers receiving patients from different parts of the country with one located in lower Myanmar and another located in central Myanmar. Based on the results of this study, normal reference values of NCS in Myanmar will be known so that patients can be more accurately diagnosed with different types of peripheral neuropathies and it will help decide on severity and prognosis accordingly. All in all, the study results will enable better interpretations of NCS in Myanmar.
Preliminary Aim : To determine the reference values for nerve conduction study among normal healthy subjects in Myanmar
Preliminary Objectives : 1. To describe the demographic characteristics of normal healthy volunteers, 2. To find out the values of motor and sensory nerve conduction studies in normal individuals
Preliminary Sample Size : Healthy controls who are companions (relatives, friends) of patients admitted to Neuromedical wards, YGH and MGH. Total sample size = 160, 40 participants (20 male vs. 20 female) for each group is required to detect the effect size of 0.3348 (σ = 5%, β = 5%).
Preliminary Study Duration : 6 months
Preliminary Study Area : Department of Neurology, Yangon General Hospital (YGH) and Mandalay General Hospital (MGH)
Preliminary Study Method : Descriptive cross-sectional study
Preliminary Research Outcome : Routine NCS includes assessment of compound muscle action potential (CMAP) and sensory nerve action potentials (SNAP) of accessible peripheral nerves in upper and lower limbs including median, ulnar, radial, medial and lateral antebrachial, superficial pe
Preliminary Research Finding : The upper or lower limit of normal of all the motor nerve conduction parameters were then calculated from ± 2 standard deviations (SD) of the means.
Preliminary Progress Report : Ethical approval was obtained from Research and ethics committee, University of Medicine 1 on 7th August 2019. Equipment validation has been done by doing nerve conduction study on 5 volunteers, to whom nerve conduction study was done by both machines in
Study Starting Date : 2019-08-07
IRB/PRC/ERC Approval Date : 2019-08-07
Placement of IRB/PRC/ERC : University of Medicine 1, Yangon
IRB/PRC/ERC Approval Letter/Document : 030220200627182019NCSref.pdf
Pre-existing Registration ID : 030/UM1,REC.2019
Pre-existing Name of Organization : Department of Neurology
Pre-existing Name of Organization Website : -