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临床试验/NCT07240142
NCT07240142已完成不适用

Biochemical and Docking Evidence of Neurotransmitter Dysregulation in Specific Learning Disorder

Dilara Ulger Ozbek2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Mesurment of serum neurotransmitters levels

研究概览

简要总结

The aim of this clinical trial was to measure how specific neurotransmitter levels in children with Specific Learning Disorder (SLD) change compared to controls. The relationship between these markers and the measured markers will be determined both theoretically and experimentally using various neuropsychological tests. The fundamental questions it aims to answer are

Did neurotransmitter levels increase or decrease in the patient group? Are the neurotransmitter levels measured in the neuropsychological tests related? Can the measured neurotransmitters be used to predict the disease?

Participants:

A single visit to the clinic, a blood sample, and neuropsychological tests will be administered on the same day.

详细描述

The purpose of this investigation was to assess the levels in serum of key neurotransmitters and their precursors (glutamate, L-arginine, and nitric oxide) in children with SLD and also to integrate these biochemical results with molecular docking analyses of their interactions with phospholipase A2 (PLA2) and N-methyl D-aspartate receptors (NMDA), both of which play significant roles in learning function in these patients.

The research group consisted of 20 children aged 7-14 years who had been diagnosed with SLD using DSM-5 criteria, as well as 20 age-matched, gender-matched, and educationally matched healthy controls. The children in the study group underwent the Stroop Test [Total Error Scores, Total Time Scores, Total Correction] and the Wechsler Intelligence Scale for Children (WISC-IV) subtests, and the results were scored. The serum concentrations of glutamate, L-arginine, and nitric oxide (NO) were determined using ELISA. The diagnostic ability of the biomarkers was evaluated using ROC analysis. Additionally, the interactions of glutamate and L-arginine with the PLA2 enzyme and the NMDA receptor were examined using molecular docking analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Study group: no additional mental disorder except a specific learning disability,
  • The control group had no mental illness.
  • Having no head injury or neurological illness for all groups.
  • There is no drug that might possibly alter cognitive functions for all populations.

排除标准

  • The study group had a mental disease other than a specific learning disability and ADHD.
  • The control group had any mental condition.
  • Having a head injury or neurological illness in all categories.
  • Using drugs that may impair cognitive functioning in all groups those with additional diseases

结局指标

主要结局

Mesurment of serum neurotransmitters levels

时间窗: 6 months

Serum Glutamate Levels (measured in µmol/L by ELISA at baseline) Serum L-Arginine Levels (measured in µmol/L by ELISA at baseline) Serum Nitric Oxide (NO) Levels (measured in µmol/L by ELISA at baseline)

Full Scale IQ (FSIQ)

时间窗: 6 months

Change in Full Scale IQ (FSIQ) score from baseline to 6 months.oints on a scale (range: 40-160; higher scores indicate better performance)

Verbal Comprehension Index (VCI)

时间窗: 6 month

Change in Verbal Comprehension Index (VCI) score from baseline to 6 months.Points on a scale (range: 40-160; higher scores indicate better performance)

Perceptual Reasoning Index (PRI)

时间窗: 6 months

Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months. Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months.

Processing Speed Index (PSI)

时间窗: 6 months

Change in Processing Speed Index (PSI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance).

Stroop Test Performance

时间窗: 6 months

Change in Stroop Test total errors, total time, and total corrections from baseline to 6 months.Seconds (for time) and number of errors/corrections; lower scores indicate better performance.

Working Memory Index (WMI)

时间窗: 6 months

Change in Working Memory Index (WMI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance)

次要结局

未报告次要终点

研究者

发起方
Dilara Ulger Ozbek
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dilara Ulger Ozbek

Dr.

Cumhuriyet University

研究点 (2)

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