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Completed

NCT Number: NCT07240142

Neurotransmitter Levels in Children With Specific Learning Disorder

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.

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Key information

Conditions

Specific Learning Disability Communication Disorders Healthy (Controls) Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, Central, 58146, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Blood Product

Procedure

Collecting 5 ml blood samples from the left atrial vein, after that obtaining serum from it.

ELISA Test

Other

Measurement of glutamate, nitric oxide, and L-arginine concentrations in the blood samples obtained using an ELISA test kit.

Primary outcomes

  1. Mesurment of serum neurotransmitters levels

    Time frame: 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)

  2. Verbal Comprehension Index (VCI)

    Time frame: 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)

  3. Perceptual Reasoning Index (PRI)

    Time frame: 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.

  4. Working Memory Index (WMI)

    Time frame: 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)

  5. Processing Speed Index (PSI)

    Time frame: 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).

  6. Stroop Test Performance

    Time frame: 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.

  7. Full Scale IQ (FSIQ)

    Time frame: 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)

Other outcomes

  1. Molecular docking analysis

    Time frame: 6 months

    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.

  2. ROC analysis performance of biomarkers

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Dilara Ulger Ozbek

Other

Registry information

Official study title

Biochemical and Docking Evidence of Neurotransmitter Dysregulation in Specific Learning Disorder

Acronym: SLD

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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