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| Principal Investigator | |
| Principal Investigator's Name: | Vorapun Senanarong |
| Institution: | Faculty of Medicine Siriraj Hospital |
| Department: | Department of Medicine, Division of Neurology |
| Country: | |
| Proposed Analysis: | The Volumetric Techniques with Brain Magnetic Resonance Imaging: A Comparative Study among Normal Cognition, Mild Cognitive Impairment and Dementia Groups OBJECTIVES AND HYPOTHESIS Objective This study aims to investigate the relationship of brain volume from MRI among healthy individual and patients with MCI and dementia in Thailand. We utilize 2 different softwares, FreeSurfer (FS, which is a research product of Harvard University) and Neuro AI (which is a research product of Soul National University) to measure the volumetric study of the brain MRI. The objectives of our study are as follows: 1. To examine the relationship of brain volume and cortical thickness in Thai normal adults, MCI and dementia patient by FreeSurfer(FS) 2. To compare the performances between FS (semi-automated technique) and Neuro AI (automated technique) in studying of brain volume and cortical thickness in Thai cohorts. 3. To calculate odds ratio of brain parameters being risk for dementia and risk for MCI. 4. To demonstrate normal brain volume in Thai cohort with normal cognition. 5. To find out the optimal combination features of brain morphologies to detect MCI and dementia in Thai population. Hypothesis 1. The brain volume in dementia and MCI are lower than normal healthy adult in Thai. 2. The combination of certain brain morphologies can give early diagnosis of dementia. 3. The combination of certain brain morphologies can give early diagnosis of MCI. 4. There is gender difference in brain morphologies of individual with normal cognition. MATERIALS AND METHODS 1. Materials 1. Study participants A total 120 Thai participants from memory clinic, department of medicine, Siriraj hospital, Mahidol University, aged between 45-75 years old, were recruited. All are required to pass inclusion and exclusion criteria were done brain MRI between 2019-2020 using dementia protocols read by radiologist in department of radiology. These participants were divided into 3 groups (N = 40 per group) by careful diagnosis from experienced neurologist using neurological examination and neuropsychological test, composed of normal control, MCI and dementia. Dementia and MCI patients are diagnosed when satisfied the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria. Dementia patient will test the dementia severity equivalent to a Clinical Dementia Rating of one or greater and they had symptoms of dementia for a period of at least 6 months. All NCDs patients will be diagnosed in subtypes and co-subtypes. 1.1 Sample size calculation Due to the prevalence of dementia in Thailand is 8.1%. The classifiers in this study will use to detect dementia and MCI. The optimal sample size would need Type I error less than or equal to 5%. The margin of error is equal to 5%. Then, calculation of sample size by the equation as show below. And the optimal sample size would be 114. So, in this study the numbers of participant could be 120. Methods 1. Participant preparation 1.1 Normal group: volunteers in this group will be test to rule out any abnormal conditions that will impact with their cognition (such as hypothyroidism, vitamin B12 deficiency) and will be examined with standard neuropsychological tests by neurologist to confirm that they are normal cognition. 1.2 NCDs groups: Dementia and MCI groups were diagnosed by neurologist. These volunteers were introduced to participate in this study by neurologist in memory clinic, department of medicine, Siriraj hospital, Mahidol University. After they have confirmed diagnosis by gold standard test and have signed inform consent, they are sent to do brain MRI. 2. MRI Volunteer will be done brain MRI with dementia protocol with image acquisition preset of MRI machine as previous mention. Philips 1.5 Tesla MRI scan is used in this study. The MRI pictures were read by radiologist from department of radiology, Siriraj hospital, Mahidol University with masked diagnosis. And it will read again by neurologist. All MRI results are read to rule out any condition that fit in exclusion criteria, brain pathology and help in diagnosis as usual. 3. Brain image analytic software MRI pictures (DICOM file) will be uploaded in FS and Neuro AI software for brain volumetric analysis. The results will be sent to Excel program manually and then selected data of interest to SPSS version 18.0 for statistical analysis. 4. Data analysis The statistical analysis of all data was done by the SPSS Program (Version 18.0). All analyses were adjusted for age, sex and educational background. The results were test if variables are normally distributed by Kolmogorov-Smirnof test. Assumed results as nonparametric distribution, it will examine sample characteristics by Friedman test (dependent) and sample correlation by Pearson correlation. If results are parametric distribution, it will test sample characteristics by repeated-measures ANOVA and sample correlation by Spearman correlation. The statistical significance level was set at p < 0.05. The volume and thickness of each brain region were obtained from the calculation of FreeSurfer and Neuro AI. For the brain volume in area of interest normalized by intracranial volume method, the absolute volume of each brain region was divided by an individual’s total intracranial volume. The Different parts of brain volumes and thickness in each group will be compared between the 2 analytic software with Pearson correlation upon a confidence level of 95%, p <0.05. We will use single measure intra-class correlation coefficient (smICC) to compare the brain volume and cortical thickness agreement between the 2 software/methods. We choose the age, sex and educational background adjusted analysis of brain volume and thickness of each groups as the primary analysis because we wished to assess whether any observed correlation was significant different between normal control and MCI, dementia. |
| Additional Investigators |
