- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Dongliang Jiao, doctor
- Puhelinnumero: 15005527903
- Sähköposti: jdl3925697@163.com
Opiskelupaikat
-
-
-
Bengbu, Kiina
- Rekrytointi
- Bengbu Medical University
-
Ottaa yhteyttä:
- Dongliang Jiao, doctor
- Puhelinnumero: 15005527903
- Sähköposti: jdl3925697@163.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
|
Muut: Single-regulation group( Neural Circuits Activation Only )
|
|
|
Muut: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Severity of Gaming Disorder
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Changes of Electrophysiological Indicators
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Dongliang Jiao, doctor, School of Mental Health, Bengbu Medical University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- dlJiao-350
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .