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Mechanism of BCI-Based Dual-Target Neurofeedback Training in Improving Cognitive Control Deficits in Internet Gaming Disorder

25. september 2026 opdateret af: The First Affiliated Hospital of Bengbu Medical University

Mechanistic Study on Brain-Computer Interface-Based Dual-Target Neurofeedback Training Intervention for Cognitive Control Deficits in Internet Gaming Disorder

Addressing the three core issues in research on cognitive control deficits in Internet Gaming Disorder (IGD)-unclear neural mechanisms, limited intervention targets, and poor patient compliance-this project innovatively constructs a pathological model of IGD characterized by "decline in social rewards → dysfunction of the dorsal Anterior Cingulate Cortex-Dorsolateral Prefrontal Cortex (dACC-DLPFC) cognitive control circuit → abnormalities in the frontal midline theta rhythm (Fmθ)." The investigators have developed a dual-target intervention system that integrates neurofeedback with social reward substitution, transforming social rewards into therapeutic reinforcers to enhance the effectiveness of the intervention.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Existing research has confirmed that cognitive control dysfunction is the core pathological mechanism underlying the onset and progression of Internet Gaming Disorder (IGD); however, there remain critical scientific questions in this field that urgently need to be addressed:

First, the underlying neural mechanisms driving cognitive control abnormalities in IGD patients have not yet been clarified. Most existing studies remain at the level of phenomenological description and have not elucidated the mechanisms of dysfunction in brain circuits related to cognitive control or the upstream regulatory factors;

Second, the cognitive control deficits in IGD patients have not yet been fundamentally remediated. Current intervention strategies focus solely on "inhibitory interventions" and fail to establish a healthy social reward system capable of replacing the immediate rewards of gaming. This leaves a gap in behavioral regulation following the correction of cognitive control deficits, resulting in a significant sense of psychological emptiness after withdrawal and persistently high rates of clinical relapse;

Third, IGD patients exhibit low participation in restorative interventions targeting cognitive control deficits, and the effects of such interventions are short-lived. IGD is generally characterized by low sensitivity to social rewards and insufficient treatment motivation. The decline in social rewards and cognitive control deficits are causally interlinked; traditional psychotherapy models that rely on verbal communication and self-disclosure struggle to adapt to these characteristics, resulting in limited therapeutic efficacy.

In light of these scientific issues, this project will conduct targeted research:

First, the investigators will innovatively construct an IGD pathological model: "social reward decline → dysfunction of the dorsal Anterior Cingulate Cortex-Dorsolateral Prefrontal Cortex (dACC-DLPFC) cognitive control circuit → abnormalities in the frontal midline theta rhythm (Fmθ)." The investigators will systematically elucidate the mechanisms, upstream drivers, and specific biomarkers underlying the dysfunction of the cognitive control circuit;

Second, based on the above theory and approaching IGD intervention from the perspective of organically combining "breaking with the old" and "establishing the new," the investigators will establish a dual-target system to repair the cognitive control circuit. Develop an Fmθ neurofeedback intervention device that "activates neural circuits and inhibits gaming behavior + promotes social rewards and substitutes for gaming behavior";

Third, transform social rewards into therapeutic reinforcers to effectively stimulate intrinsic motivation for cognitive control restoration, thereby significantly improving compliance and engagement in IGD cognitive control interventions.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
120

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Kina
      • Bengbu, Kina
        • Rekruttering
        • Bengbu Medical University
        • Kontakt:

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Individuals aged between 18 and 35 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations
  • Consent to actively cooperate in the completion of subsequent follow-up assessments
  • Right-handed
  • The Gaming Disorder Screening (GDSS) Scale score ≥ 47 points
  • Average weekly gaming time greater than 21 hours, maintained for over one year
  • More than 50% of daily internet time spent playing online games

Exclusion Criteria:

  • Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months
  • Left-handed
  • An intellectual disability with an IQ score less than 70
  • A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria
  • Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years
  • Severe organic diseases that might compromise study participation
  • Color blindness or color weakness

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Dual-regulation group
  1. Conduct a single-blind, randomized controlled trial. 40 participants assigned to the dual-regulation group will receive a full course of "neural circuit activation + social reward promotion" dual neurofeedback training.
  2. Assessments, including standardized scales, behavioral tests, and neuroimaging, will be conducted once before and once after the intervention.
  3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions.
  4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points:baseline (T0, Time Point 0), immediately post-intervention (T1, Time Point 1), 6-month follow-up (T2, Time Point 2) and 12-month (T3, Time Point 3) follow-ups.
Adfærdsmæssigt: "Activate Neural Circuits + Promote Social Rewards" Dual-target Neurofeedback Training

Using the MATLAB environment, the PsychToolbox add-on, and the integrated EEGLAB toolbox for real-time EEG signal processing, a neural feedback system was constructed to enable precise, targeted regulation of the dACC-DLPFC circuit.

Target 1 (activating neural circuits to inhibit gaming behavior [breaking old habits]) and Target 2 (promoting social rewards to replace gaming behavior [establishing new habits])-this dual-target design forms a complete learning loop of "inhibiting impulses → obtaining healthy rewards," simulating the behavioral patterns of a healthy brain.

A three-group between-subjects design was employed to isolate the unique effects of the "social reward" component; each session consisted of 30 minutes of neurofeedback training, four times a week, for four consecutive weeks.

Dual-regulation group: Received comprehensive "neural circuit activation + promotion of social reward" dual neurofeedback training.
Andet: Single-regulation group（ Neural Circuits Activation Only ）
  1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the single-regulation group will receive only "inhibitory" neurofeedback training targeting the dACC-DLPFC (dorsal Anterior Cingulate Cortex - Dorsolateral Prefronteral Prefronta Cortex) circuit (activating the neural circuit only, without promoting social reward).
  2. Assessments will include standardized scales, behavioral tests, and neuroimaging, each administered once before and after the intervention.
  3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions.
  4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.
Adfærdsmæssigt: "Activate Only the Neural Circuits" Neurofeedback Training
  1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the single-modulation group will receive only "inhibitory" neurofeedback training targeting the dACC-DLPFC circuit (activating the neural circuit only, without promoting social reward).
  2. Assessments will include standardized scales, behavioral tests, and neuroimaging, each administered once before and after the intervention.
  3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions.
  4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.
Andet: Sham Feedback group (none contingent feedback)
  1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the sham feedback group will follow the same task protocol but receive sham feedback unrelated to their own brain activity.
  2. Assessments, including standardized scales, behavioral tests, and neuroimaging, will be conducted once before and once after the intervention.
  3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions.
  4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.
Adfærdsmæssigt: Sham Feedback

1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the sham feedback group will follow the same task protocol but receive sham feedback unrelated to their own brain activity. 2. Assessments, including standardized scales, behavioral tests, and neuroimaging, will be conducted once before and once after the intervention.3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions. 4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of Gaming Disorder
Tidsramme: through neurofeedback training completion, an average of 1 month

The severity of gaming disorder was assessed using the Gaming Disorder Screening Scale (GDSS), which consists of 18 Likert-scale items. Each item has four response options (1 = never; 2 = sometimes; 3 = often; 4 = always), with a total score range of 18 to 72. Based on receiver operating characteristic (ROC) analysis using ICD-11 as the gold standard, a total score of ≥47 indicates a high risk of gaming disorder
through neurofeedback training completion, an average of 1 month
Results of Neurofeedback Training
Tidsramme: through neurofeedback training completion, an average of 1 month

Results of Neurofeedback Training:Average increase in frontal midline theta (Fmθ) power during training. The higher the power, the better theresults
through neurofeedback training completion, an average of 1 month
Results of Neurofeedback Training
Tidsramme: through neurofeedback training completion, an average of 1 month

Results of Neurofeedback Training:The time it takes for participants to reach a predetermined target energy level. The shorter the time, the better the training results.
through neurofeedback training completion, an average of 1 month
Changes of Behavioral Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Stop-Signal Reaction Time (SSRT) derived from the Social Reward-modified Stop-Signal Task. Shorter SSRT indicates better cognitive control performance under social-reward versus no-reward conditions.
through neurofeedback training completion, an average of 1 month
Changes of Behavioral Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Stop-Signal Delay (SSD) derived from the Social Reward-modified Stop-Signal Task. Higher SSD indicates better cognitive control performance under social-reward versus no-reward conditions.
through neurofeedback training completion, an average of 1 month
Changes of Behavioral Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Hit rate derived from the Social Incentive Delay Task. Reduced hit rate under social-reward cue conditions indicates impaired social reward processing.
through neurofeedback training completion, an average of 1 month
Changes of Behavioral Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Reaction time for correct hits derived from the Social Incentive Delay Task. Prolonged reaction time under social-reward cue conditions indicates impaired social reward processing.
through neurofeedback training completion, an average of 1 month
Social Reward
Tidsramme: through neurofeedback training completion, an average of 1 month

The social reward function was measured using the "Social Pleasure" subscale of the Multidimensional Pleasure Deficit Scale. This subscale consists of four items. Participants were first asked to list two current or past social activities that had brought them pleasure, and then to respond to each item, assessing factors such as their willingness to participate in these activities and the level of pleasure experienced during participation. Scoring is based on a 10-point Likert scale, ranging from "Not at all" to "Very much." Higher scores indicate stronger social reward.
through neurofeedback training completion, an average of 1 month
Executive Function
Tidsramme: through neurofeedback training completion, an average of 1 month

Executive function was evaluated using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A), comprising 75 items scored on a 3-point Likert scale ranging from "never" to "often." Higher scores on the Global Executive Composite (GEC) reflect greater executive function impairment.
through neurofeedback training completion, an average of 1 month

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of Electrophysiological Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Event-related potential (ERP) components N200 elicited during the Stop-Signal Task were analyzed with respect to amplitude . N200 amplitude indexed conflict monitoring.
through neurofeedback training completion, an average of 1 month
Changes of Electrophysiological Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Event-related potential (ERP) components P300 elicited during the Stop-Signal Task were analyzed with respect to latency. P300 latency reflected inhibitory control capacity.
through neurofeedback training completion, an average of 1 month
Neuroimaging Indicators
Tidsramme: through neurofeedback training completion, an average of 1 month

Functional magnetic resonance imaging (fMRI) was used to assess the strength of functional connectivity between the dorsal anterior cingulate cortex (dACC) and the dorsolateral prefrontal cortex (DLPFC)
through neurofeedback training completion, an average of 1 month

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
The First Affiliated Hospital of Bengbu Medical University

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Bengbu Medical University

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studiestol: Dongliang Jiao, doctor, School of Mental Health, Bengbu Medical University

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. januar 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
30. december 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
30. december 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
20. juli 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
25. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
28. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
25. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • dlJiao-350

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

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