NCT07240142

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

September 30, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Specific learning DisorderGlutamateL-argininenitric oxidemolecualr docking

Outcome Measures

Primary Outcomes (7)

  • 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)

    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)

    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.

    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)

    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).

    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.

    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)

    6 months

Other Outcomes (2)

  • Molecular docking analysis

    6 months

  • ROC analysis performance of biomarkers

    6 months

Study Arms (1)

Collection of blood samples

EXPERIMENTAL

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 ProductOther: Elisa test

Interventions

Blood ProductPROCEDURE

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

Collection of blood samples

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

Collection of blood samples

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Central, 58146, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Specific Learning Disorder

Condition Hierarchy (Ancestors)

Learning DisabilitiesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Dilara ULGER OZBEK, Dr.

    Cumhuriyet University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Blood sample collection
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 30, 2025

First Posted

November 20, 2025

Study Start

October 22, 2019

Primary Completion

October 21, 2020

Study Completion

April 16, 2021

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations