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Neurotrophic Factors, Impulsivity, and Reward Sensitivity in Children With Internet Gaming Disorder

10. maj 2026 opdateret af: Kerim Kızıltan, Istanbul Saglik Bilimleri University

Investigation of the Relationship Between Serum BDNF and GDNF Levels and Impulsivity, Reward/Punishment Sensitivity in Children Diagnosed With Internet Gaming Disorder

Research and knowledge regarding the neurobiology of behavioral addictions and Internet Gaming Disorder (IGD) remain limited compared to substance and alcohol use disorders. However, IGD is increasingly causing significant functional impairment, particularly in the child and adolescent population. The primary objective of this study is to measure the serum levels of Brain-Derived Neurotrophic Factor (BDNF) and Glial-Derived Neurotrophic Factor (GDNF)-both known for their roles in neurogenesis and neuroprotective effects-in a patient group aged 10-14 and a healthy control group. Additionally, this study aims to investigate the relationship between these neurotrophic factor levels and disease severity, as well as various behavioral and emotional parameters measured through psychometric assessments, to identify differences between the patient and healthy populations.

Researchers will compare IGD patient group with healthy control group, both aged 10-14.

Participants and their parents will be asked to fill self-report measures and serum samples of participants will be collected for BDNF and GDNF level measurements.

The main questions of the study are:

  • Is there a difference in serum BDNF and GDNF levels between IGD patient group and healthy controls?
  • Is there a relation between serum BDNF and GDNF levels and IGD severity?
  • Is there a difference in impulsivity, reward/punishment sensitivity between IGD patient group and healthy controls
  • Is there a relation between serum BDNF and GDNF levels and impulsivity, reward/punishment sensitivity scores in IGD patient group?

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Between May 2026 and December 2026, informed consent and assent will be obtained from participants and their parents/legal guardians after a comprehensive explanation of the study objectives, psychometric scales, and psychiatric evaluation protocols. This research is designed as a cross-sectional case-control study. The patient group will include children and adolescents diagnosed with Internet Gaming Disorder (IGD) according to DSM-5 criteria. The control group will consist of age- and gender-matched individuals attending psychiatry or pediatric outpatient clinics or volunteers who meet the control inclusion criteria and have provided written informed consent.

The primary investigator will conduct clinical psychiatric interviews with all participants in both the case and control groups to verify eligibility and diagnostic status. The following psychometric instruments will be administered:

For children (Case and Control groups): Internet Gaming Disorder Scale-Short Form (IGDS9-SF), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), UPPS-P Impulsive Behavior Scale for Children (C-UPPS-P), Screen for Child Anxiety Related Emotional Disorders (SCARED) - Child Form, and Children's Depression Inventory (CDI).

For parents (Case and Control groups): SCARED - Parent Form, and the Turgay DSM-IV-based Screening and Assessment Scale for Disruptive Behavior Disorders (Turgay ADHD Scale).

Joint Assessments: The Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) and a sociodemographic data form will be administered to both the children and their parents by the researcher.

For biochemical analysis, peripheral venous blood samples will be collected from all participants following a 10-12 hour fasting period between 09:00 and 12:00. Samples will be drawn into gold-top (serum separator) tubes and transported within 2-3 hours to the Brain and Neurodegenerative Diseases Research Laboratory at Istanbul University-Cerrahpaşa, Institute of Neurological Sciences, Department of Neuroscience. Blood tubes will be centrifuged at 5000 rpm for 10 minutes. The separated serum will be aliquoted into 1.5 ml microcentrifuge tubes and stored at -80°C until the final analysis. Once the sample collection phase is complete, serum BDNF and GDNF levels will be determined using Human BDNF (ELH-BDNF-1, RayBiotech) and Human GDNF (ELH-GDNF-1, RayBiotech) ELISA kits. ELISA assays will be conducted strictly following the manufacturers' protocols at the aforementioned laboratory.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Bakirkoy
      • Istanbul, Bakirkoy, Tyrkiet (Türkiye)
        • Rekruttering
        • Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatry, Neurology, and Neurosurgery

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of children and adolescents who visit the Child and Adolescent Psychiatry outpatient clinics at Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatry, Neurology, and Neurosurgery between May 2026 and December 2026. The participants will include a patient group meeting the specific inclusion criteria for Internet Gaming Disorder and an age- and gender-matched healthy control group. The control group will be recruited from volunteers attending the psychiatry or pediatric outpatient clinics of the same hospital who meet the control criteria. All participants and their legal guardians will be volunteers who have provided written informed consent after a detailed explanation of the study.

Beskrivelse

Inclusion Criteria:

For IGD Patient Group:

Age: Being between 10 and 14 years of age. Literacy: Ability to read and write fluently. Informed Consent: Voluntary participation with written informed consent obtained from both the participants and their parents/legal guardians after a comprehensive briefing on the study procedures and scales.

Diagnostic Criteria: Meeting the DSM-5 diagnostic criteria for Internet Gaming Disorder (IGD) and scoring above the clinical cutoff on the Internet Gaming Disorder Scale-Short Form (IGDS9-SF).

For Healthy Control Group:

Age: Children between 10 and 14 years of age. Literacy: Ability to read and write fluently. Clinical Status: No history or current diagnosis of any neuropsychiatric disorder, confirmed through clinical psychiatric assessment.

Informed Consent: Voluntary participation with written informed consent obtained from both the participants and their parents/legal guardians after a comprehensive briefing on the study procedures and scales.

Exclusion Criteria:

Comorbid Psychiatric Disorders: Meeting the DSM-5 diagnostic criteria for Autism Spectrum Disorder, Schizophrenia, Bipolar I Disorder, or Bipolar II Disorder.

Cognitive and Neurological Impairment: Having a moderate to severe intellectual disability and/or a neurological disease in either the child or the caregiver that would impede the ability to understand instructions or provide reliable responses during the interview.

Lack of Informed Consent: Refusal to participate voluntarily or failure to sign the informed consent/assent form by the children or their parents/legal guardians after receiving a detailed explanation of the study's purpose and the assessment scales to be administered.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
IGD Patient Group
The patient group consists of children aged 10-14 who meet the DSM-5 diagnostic criteria for Internet Gaming Disorder (IGD). Participants are required to be literate and to have provided written informed consent along with their legal guardians after a comprehensive explanation of the study protocols.
Andet: Clinical Evaluation and Biochemical Sampling
Participants and their parents will undergo a cross-sectional clinical psychiatric interview conducted by a child and adolescent psychiatrist. Following the interview, both participants and their parents will be required to complete a battery of standardized self-report and parent-report psychometric scales. At the conclusion of the clinical assessment, a peripheral venous blood sample will be collected from each participant for serum biochemical analysis of neurotrophic factors (BDNF and GDNF).
Healthy Control Group
The healthy control group consists of volunteer children aged 10-14 who have no current or past history of neuropsychiatric disorders based on comprehensive clinical psychiatric evaluations. Participants are required to be literate and to have provided written informed consent along with their legal guardians, following a detailed explanation of the study's objectives and the assessment scales to be administered.
Andet: Clinical Evaluation and Biochemical Sampling
Participants and their parents will undergo a cross-sectional clinical psychiatric interview conducted by a child and adolescent psychiatrist. Following the interview, both participants and their parents will be required to complete a battery of standardized self-report and parent-report psychometric scales. At the conclusion of the clinical assessment, a peripheral venous blood sample will be collected from each participant for serum biochemical analysis of neurotrophic factors (BDNF and GDNF).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of Serum BDNF and GDNF Levels
Tidsramme: Baseline (at the time of enrollment)
Serum concentrations of Brain-Derived Neurotrophic Factor (BDNF) and Glial-Derived Neurotrophic Factor (GDNF) will be measured in picograms per milliliter (pg/mL) to identify biological differences between the Internet Gaming Disorder (IGD) group and healthy controls.
Baseline (at the time of enrollment)
Differences in Impulsivity and Reward/Punishment Sensitivity Scores
Tidsramme: Baseline (at the time of enrollment)
Comparison of psychometric assessment scores between the IGD group and healthy controls to evaluate behavioral differences.
Baseline (at the time of enrollment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between Neurotrophic Factors and Behavioral Scores in the IGD Group
Tidsramme: Baseline
Analyzing the specific relationship between serum BDNF/GDNF levels and psychometric scores of impulsivity and reward/punishment sensitivity within the patient group diagnosed with Internet Gaming Disorder (IGD).
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul Saglik Bilimleri University

Samarbejdspartnere

Istanbul University - Cerrahpasa

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

10. maj 2026

Først indsendt, der opfyldte QC-kriterier

10. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026/148

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The participants' age, scores of the clinical scales examined in the study, and levels of serum samples will be shared. In other words, the necessary data relevant to the purpose of the study will be shared.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Internet Gaming Disorder

Kliniske forsøg med Clinical Evaluation and Biochemical Sampling

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