Global Journal of Medical Research, A: Neurology & Nervous System, Volume 23 Issue 3
III. M ethodology 1. Participants The study included a total number of participants 283 (76 males/207 females) who had visited the 2nd Neurology Department of Attikon University in the last 18 months, they were examined by experienced neurologists and psychologists who recorded data such as demographics and disease history. It is a convenient sample. The mean age of the subjects was 52,7 years, with a range 19-90; the mean number of years of education was 13 years with a range of 3-21 years. The subjects were divided based on their diagnosis and health control, therefore, patients with MCI (n = 44; 15.5 % of the total sample), patients with Dementia types (n = 58: Dementia=39, AD =19, 20.1%), patients with MS (n = 68; 24.0% of the total sample), patients with SLE (n = 71, 25.1% of the total sample), and the healthy controls (n = 43; 15.2% of the total sample) (please, see Table 1). The recruitment of participants diagnosed with Dementia spectrum and Mild Cognitive Impairment (MCI) were enrolled based on their magnetic resonance imaging (MRI) findings and other relevant clinical assessments conducted prior to their inclusion in the study. The examinations encompass the analysis of specific molecules, namely phosphorylated tau (p-tau) and amyloid-beta (A β ), which have been extensively researched in relation to mild cognitive impairment (MCI) and Alzheimer's disease (AD). Also, biomarkers, such as cerebrospinal fluid (CSF) levels of p-tau and A β , along with neuroimaging measures like frontotemporal type (FT-MCI), frontotemporal dementia (FTD), and normal pressure hydrocephalus (NPH), are being investigated as potential diagnostic and prognostic markers for mild cognitive impairment (MCI) and its progression to dementia. Inclusion criteria were diagnosis of the following diseases: dementia and Alzheimer’s Disease based on DSM ‐ V, with a previous clinical examination with cerebrospinal fluid (CSF) biomarker measurements such as beta-amyloid 42, tau, and phospho-tau as they are considered a hallmark for the diagnosis (Ashton et al., 2022), and structural brain imaging (CT or MRI); the individuals with MS were recruited as they had a definite diagnosis of MS according to the McDonald criteria 2017 (McDonald Criteria, 2022), their clinical condition was stable without relapses the last 6 months, they had MRI and they had expressed cognitive issues also they had previous examinations with biomarkers such as IL-6, CD14 e.g ; individuals with SLE with a diagnosis that meet the revised American College of Rheumatology (ACR) classification criteria, they had an MRI and had expressed cognitive issues; Healthy controls were random health visitors of the clinic as well as university students. Additional inclusion criteria; All participants were aged over 18 years, able to speak and read Greek fluently, and provide themself or/and their caregivers with full detailed information and consent forms. Exclusion criteria were any type of comorbidities such as cardiovascular disease and psychiatric disorder; individuals with motor deficits in handwriting; other reasons such as medication or/and alcohol use that may affect participants’ mental function and/or mental health; participants with a covid-19 diagnosis were excluded. 2. Ethics The researchers requested permission from Professor Donald Royall, the creator of CLOX: Clock Drawing Executive Test. The researchers were granted permission, thereby facilitating the validation process to proceed. Following that, the investigators provided a thorough account of the research protocol, encompassing the methodologies for conducting the study and acquiring approval from the Attikon University Hospital Ethics Committee. The reference number assigned to the protocol in question is identified as 'BNEYR, EBD366/16-7-2021'. The researchers followed the guidelines specified in the General Data Protection Regulation (GDPR) throughout the entire study, thus guaranteeing the safeguarding of the participants' information. 3. Procedure All stages of the protocol were conducted at Attikon University Hospital. The participants recruited in the 2nd Neurological Department were assessed using interviews and a neuropsychological examination. The chosen location was specifically designed to facilitate the administration of the psychometric test in a controlled environment, devoid of any extraneous stimuli, such as sound. The process began by informing the participants about their involvement. After obtaining their consent, the interview proceeded by gathering demographic information and relevant documentation, including MRIs and biomarker tests, to validate their condition. The participants subsequently underwent a series of neuropsychological tests. The recruitment process spans a period of 18 months. The researchers implemented comprehensive measures to ensure the well-being of the participants, specifically focusing on mitigating the risks associated with the COVID-19 pandemic. or the diagnosis (Ashton et al., 2022), and structural brain imaging (CT or MRI); the individuals with MS were recruited as they had a definite diagnosis of MS according to the McDonald criteria 2017 (McDonald Criteria, 2022), their clinical condition was stable without relapses the last 6 months, they had MRI and they had expressed cognitive issues also they had previous examinations with biomarkers such as IL-6, CD14 e.g; individuals with SLE with a diagnosis that meet the revised American College of Rheumatology (ACR) classification criteria, they had an MRI and had expressed cognitive issues; Healthy controls were random health visitors of the clinic as well as university 61 Year 2023 Global Journal of Medical Research Volume XXIII Issue III Version I ( D ) A © 2023 Global Journals Reliability and Validity Evaluation of the ‘’CLOX: An Executive Clock Drawing Task’’ in a Greek Population with Neurological and Autoimmune Diseases
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