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Neurofeedback Training for Adolescents and Young Adults With Borderline Intellectual Functioning (NFB-BIF)

5. listopadu 2026 aktualizováno: Yerin Hong, Seoul University of Buddhism

The Effects of Sequential Alpha-Low-Beta Neurofeedback on Mental Health, Social Skills, Attention and QEEG in Adolescents and Young Adults With Borderline Intellectual Functioning: A Randomized Waitlist-Controlled Pilot Trial

This randomized waitlist-controlled pilot trial examines whether sequential alpha (8-12 Hz) and low-beta (12-15 Hz) neurofeedback training improves mental health, social skills, attention, and quantitative EEG (QEEG) in adolescents and young adults with borderline intellectual functioning (slow learners). Thirteen participants aged 13 to 39 years were randomly assigned to a neurofeedback group (n = 7) or a waitlist control group (n = 6). The neurofeedback group completes 20 sessions (twice weekly, 50 minutes each) using a 2-channel prefrontal (Fp1, Fp2) headband device. Outcomes are assessed before and after the intervention period. The primary outcome is mean reaction time on the Psychomotor Vigilance Test (PVT). Secondary outcomes include the Brief Symptom Inventory-18 (BSI-18), the Korean Social Skills Rating System for college students (K-SSRS), PVT lapse rate, and 19-channel QEEG relative power.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

Background: Individuals with borderline intellectual functioning (BIF) fall between intellectual disability and average intellectual functioning and often lack access to formal disability services. Their difficulties in mental health, social functioning, and attention can be understood as manifestations of a common vulnerability in self-regulation (emotional, behavioral, and cognitive), which is closely related to prefrontal cortex function. Because prefrontal maturation continues from adolescence into young adulthood, this transitional period may be particularly responsive to intervention. Neurofeedback is a non-invasive, non-pharmacological method that trains individuals to self-regulate their brain activity through real-time feedback.

Design: Randomized pretest-posttest control group design with an embedded qualitative component (embedded mixed methods design). After recruitment was completed, 13 eligible participants were assigned to the experimental or waitlist control group in a single batch by simple randomization using a computer-generated random sequence (Research Randomizer). Participants were not blinded. Post-test QEEG recordings were performed by a research assistant unaware of group allocation and by the principal investigator, who was not blinded.

Intervention: Each 50-minute session consists of 5 minutes of baseline stabilization with diaphragmatic breathing, 20 minutes of alpha (8-12 Hz) neurofeedback, a 5-minute rest, and 20 minutes of low-beta (12-15 Hz) neurofeedback, delivered with the NeuroBrain device (Neuro21, Korea), which records from Fp1 and Fp2. Auditory and visual feedback is provided when the target frequency reaches the threshold. Training is delivered twice weekly for 20 sessions (August 18 to October 31, 2026). The waitlist group maintains usual daily activities and is offered the same training after the study.

Measurements: 19-channel resting-state eyes-closed EEG (BrainMaster Discovery, linked-ear montage, impedance 5 kOhm or below) analyzed with NeuroGuide; BSI-18; K-SSRS (college version); 5-minute PVT implemented in PsychoPy; and a 5-item researcher-developed social validity questionnaire (experimental group, post-test only). Experimental group participants who give separate consent take part in an approximately 30-minute semi-structured interview after the post-test, analyzed by thematic analysis (Braun & Clarke, 2006).

Analysis: Because of the small sample, all inferential tests are non-parametric (two-sided alpha = .05). Within-group changes are tested with the Wilcoxon signed-rank test and between-group differences in change scores (post minus pre) with the Mann-Whitney U test, reporting exact p values and effect size r (= Z / sqrt(N)). Associations among change scores are examined with Spearman correlation. Per-protocol analysis includes participants attending at least 16 of 20 sessions (80%). A sensitivity analysis repeats the analyses in participants aged 19 years or older. Because the initially planned sample (N = 44, G*Power) could not be reached, the study is conducted as a pilot study and effect sizes will inform future sample size estimation.

Typ studie

Intervenční

Zápis (Aktuální)

13

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Jižní Korea
      • Seoul, Jižní Korea
        • Hong Yerin Brain Health Institute
      • Seoul, Jižní Korea
        • Magok Cultural Center
      • Seoul, Jižní Korea
        • Seoul University of Buddhism, Institute of Brain Science

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

13 let až 39 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Aged 13 to 39 years and, for those of school age, enrolled in middle school or above
  • Full-scale IQ of 71-84 on the K-WAIS-IV or K-WISC-V, or officially identified as a slow learner by a borderline intellectual functioning support organization (participants identified by a support organization without a diagnosis of intellectual disability may have an IQ below 71)
  • Able to communicate in Korean and complete self-report questionnaires
  • Vision and hearing sufficient for neurofeedback training
  • Voluntary written informed consent; for participants under 19 years, written consent from a legal guardian as well

Exclusion Criteria:

  • Neurological disorders that may affect EEG measurement or interpretation (e.g., epilepsy, brain tumor, stroke)
  • Diagnosis of intellectual disability
  • Major mental health crisis within the past 6 months
  • Previous neurofeedback training
  • Use of implanted electronic medical devices (e.g., pacemaker, cochlear implant)

Psychiatric medication use is not an exclusion criterion; medication names and use are recorded and considered in interpretation.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Neurofeedback

Sequential alpha-low-beta neurofeedback training, 20 sessions, twice weekly, 50 minutes per session.
Přístroj: Sequential Alpha-Low-Beta Neurofeedback

Neurofeedback using a 2-channel prefrontal (Fp1, Fp2) headband device (NeuroBrain, Neuro21, Korea). Each 50-minute session comprises 5 minutes of baseline stabilization with diaphragmatic breathing, 20 minutes of alpha (8-12 Hz) training, a 5-minute rest, and 20 minutes of low-beta (12-15 Hz) training, with auditory and visual feedback when target activity is reached. Twenty sessions are delivered twice weekly.

Ostatní jména:
  • NeuroBrain neurofeedback
Žádný zásah: Waitlist Control

Participants maintain usual daily activities during the study period and are offered the same neurofeedback training after study completion.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Mean Reaction Time on the Psychomotor Vigilance Test (PVT)
Časové okno: Baseline and Week 13

Mean reaction time (milliseconds) on a 5-minute Psychomotor Vigilance Test implemented in PsychoPy (interstimulus interval 1-4 s). Change is calculated as Week 13 minus baseline. Baseline is the pre-test before the first training session; Week 13 is the post-test after completion of the 20-session intervention. Lower values indicate better sustained attention.
Baseline and Week 13

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in PVT Lapse Rate
Časové okno: Baseline and Week 13

Percentage of Psychomotor Vigilance Test responses slower than 500 ms. Change is calculated as Week 13 minus baseline. Lower values indicate fewer attentional lapses.
Baseline and Week 13
Change in Brief Symptom Inventory-18 (BSI-18) Total and Subscale Scores
Časové okno: Baseline and Week 13

Brief Symptom Inventory-18: 18 items rated from 0 (not at all) to 4 (extremely); somatization, depression, and anxiety subscales (6 items each; range 0-24) and total score (range 0-72). Higher scores indicate greater psychological distress (worse outcome). Change is calculated as Week 13 minus baseline.
Baseline and Week 13
Change in Korean Social Skills Rating System for College Students (K-SSRS) Total and Subscale Scores
Časové okno: Baseline and Week 13

Korean version of the Social Skills Rating System for college students: 27 items rated from 1 (never) to 7 (very often); empathy, cooperation, self-control, and assertion subscales; total score range 27-189. Higher scores indicate better social skills (better outcome). Change is calculated as Week 13 minus baseline.
Baseline and Week 13
Change in QEEG Relative Power (Theta, Alpha, Low-Beta)
Časové okno: Baseline and Week 13

FFT relative power (percentage of total power) of theta (4-8 Hz), alpha (8-12 Hz), and low-beta (12-15 Hz) bands from 19-channel eyes-closed resting EEG, analyzed with NeuroGuide. Change is calculated as Week 13 minus baseline.
Baseline and Week 13
Change in QEEG Theta/Beta Ratio
Časové okno: Baseline and Week 13

Ratio of theta (4-8 Hz) power to beta power (unitless ratio) from 19-channel eyes-closed resting EEG, analyzed with NeuroGuide. Change is calculated as Week 13 minus baseline.
Baseline and Week 13

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in QEEG Interhemispheric Amplitude Asymmetry (Exploratory)
Časové okno: Baseline and Week 13

Amplitude asymmetry (percentage) between homologous electrode pairs from 19-channel eyes-closed resting EEG, analyzed with NeuroGuide. Change is calculated as Week 13 minus baseline.
Baseline and Week 13
Correlations Among Change Scores
Časové okno: Baseline and Week 13

Spearman rank correlation coefficients (rho, range -1 to 1) among change scores (Week 13 minus baseline) in BSI-18, K-SSRS, PVT, and QEEG variables, examining whether changes in emotional, behavioral, and cognitive self-regulation are related.
Baseline and Week 13
Social Validity Questionnaire Total Score
Časové okno: Week 13

Researcher-developed 5-item Social Validity Questionnaire covering goal importance (2 items), procedure acceptability (2 items), and perceived effect (1 item), each rated from 1 (strongly disagree) to 5 (strongly agree); total score range 5-25. Higher scores indicate greater acceptability (better outcome). Experimental group only, assessed at the Week 13 post-test.
Week 13
Participants' Perceptions of Training Experience and Daily-Life Changes
Časové okno: Week 13 to Week 15

Themes from an approximately 30-minute individual semi-structured interview conducted after the Week 13 post-test, analyzed by thematic analysis (Braun & Clarke, 2006). Experimental group participants who give separate consent.
Week 13 to Week 15
Change in QEEG Coherence (Exploratory)
Časové okno: Baseline and Week 13

Coherence (percentage, 0-100) between electrode pairs from 19-channel eyes-closed resting EEG, analyzed with NeuroGuide. Change is calculated as Week 13 minus baseline.
Baseline and Week 13
Change in QEEG Phase Lag (Exploratory)
Časové okno: Baseline and Week 13

Phase lag (degrees) between electrode pairs from 19-channel eyes-closed resting EEG, analyzed with NeuroGuide. Change is calculated as Week 13 minus baseline.
Baseline and Week 13

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Seoul University of Buddhism

Spolupracovníci

Magok Cultural Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yerin Hong, Seoul University of Buddhism

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

8. srpna 2026

Primární dokončení (Odhadovaný)

7. listopadu 2026

Dokončení studie (Odhadovaný)

21. listopadu 2026

Termíny zápisu do studia

První předloženo

2. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

5. listopadu 2026

První zveřejněno (Aktuální)

12. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 27004121AN01-202606-HR-090-03

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared because participants include minors and adults with borderline intellectual functioning, and consent was not obtained for data sharing beyond the research team.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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