- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07843615
Mechanism of BCI-Based Dual-Target Neurofeedback Training in Improving Cognitive Control Deficits in Internet Gaming Disorder
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Dongliang Jiao, doctor
- Numero di telefono: 15005527903
- Email: jdl3925697@163.com
Luoghi di studio
-
-
-
Bengbu, Cina
- Reclutamento
- Bengbu Medical University
-
Contatto:
- Dongliang Jiao, doctor
- Numero di telefono: 15005527903
- Email: jdl3925697@163.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Dual-regulation group
|
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. |
|
Altro: Single-regulation group( Neural Circuits Activation Only )
|
|
|
Altro: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Severity of Gaming Disorder
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes of Electrophysiological Indicators
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Dongliang Jiao, doctor, School of Mental Health, Bengbu Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- dlJiao-350
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .