An interventional study of Blood Product and Elisa test in Specific Learning Disability and Healthy (Controls), sponsored by Dilara Ulger Ozbek. Completed at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Dilara Ulger Ozbek · Not applicable, Interventional, and Basic science
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.
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.
24 studies on the registry are indexed under Specific Learning Disorder; 4 are open to participants now.
This study's enrollment of 40 is below the median of 153 across 16 interventional studies indexed under Specific Learning Disorder.
Browse Specific Learning Disorder studies →This is the only study on the registry with Dilara Ulger Ozbek as lead sponsor.
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Exclusion Criteria:
A 5 ml blood sample will be taken from the left arterial vein of the individuals in the study group, and serum will be obtained from it. The neurotransmitter concentrations specified in the serum samples will be measured with an ELISA test kit.
Procedure: Blood Product · Other: Elisa test
Collecting 5 ml blood samples from the left atrial vein, after that obtaining serum from it.
Measurement of glutamate, nitric oxide, and L-arginine concentrations in the blood samples obtained using an ELISA test kit.
Mesurment of serum neurotransmitters levels
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)
Time frame: 6 months
Verbal Comprehension Index (VCI)
Change in Verbal Comprehension Index (VCI) score from baseline to 6 months.Points on a scale (range: 40-160; higher scores indicate better performance)
Time frame: 6 month
Perceptual Reasoning Index (PRI)
Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months. Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months.
Time frame: 6 months
Working Memory Index (WMI)
Change in Working Memory Index (WMI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance)
Time frame: 6 months
Processing Speed Index (PSI)
Change in Processing Speed Index (PSI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance).
Time frame: 6 months
Stroop Test Performance
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.
Time frame: 6 months
Full Scale IQ (FSIQ)
Change in Full Scale IQ (FSIQ) score from baseline to 6 months.oints on a scale (range: 40-160; higher scores indicate better performance)
Time frame: 6 months
Molecular docking analysis
Binding affinity values (in kcal/mol) of Glutamate and L-Arginine ligands to NMDA receptor and PLA2 enzyme active sites will be evaluated using molecular docking analysis. Lower binding affinity (more negative kcal/mol) indicates stronger interaction.Lower (more negative) binding energy indicates a stronger binding affinity.
Time frame: 6 months
ROC analysis performance of biomarkers
Receiver Operating Characteristic (ROC) analysis will be performed to determine the diagnostic performance of selected biomarkers. Parameters include Area Under the Curve (AUC), sensitivity, specificity, cut-off value, and Youden Index. AUC value (range 0-1); higher values indicate better diagnostic performance.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in Oct 2020, 11 months.
Of 15 interventional studies with no phase under Specific Learning Disorder, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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