An interventional study of Sequential Alpha-Low-Beta Neurofeedback in Borderline Intellectual Functioning, sponsored by Seoul University of Buddhism. Active, not recruiting at 3 sites in South Korea. Open to participants aged 13 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Seoul University of Buddhism · Not applicable, Interventional, and Treatment
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.
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.
169 studies on the registry are indexed under Self-Control; 22 are open to participants now.
This study's enrollment of 13 is below the median of 88 across 145 interventional studies indexed under Self-Control.
Browse Self-Control studies →Seoul University of Buddhism is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Psychiatric medication use is not an exclusion criterion; medication names and use are recorded and considered in interpretation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sequential alpha-low-beta neurofeedback training, 20 sessions, twice weekly, 50 minutes per session.
Device: Sequential Alpha-Low-Beta Neurofeedback
Participants maintain usual daily activities during the study period and are offered the same neurofeedback training after study completion.
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.
Also known as: NeuroBrain neurofeedback
Change in Mean Reaction Time on the Psychomotor Vigilance Test (PVT)
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.
Time frame: Baseline and Week 13
Change in PVT Lapse Rate
Percentage of Psychomotor Vigilance Test responses slower than 500 ms. Change is calculated as Week 13 minus baseline. Lower values indicate fewer attentional lapses.
Time frame: Baseline and Week 13
Change in Brief Symptom Inventory-18 (BSI-18) Total and Subscale Scores
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.
Time frame: Baseline and Week 13
Change in Korean Social Skills Rating System for College Students (K-SSRS) Total and Subscale Scores
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.
Time frame: Baseline and Week 13
Change in QEEG Relative Power (Theta, Alpha, Low-Beta)
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.
Time frame: Baseline and Week 13
Change in QEEG Theta/Beta Ratio
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.
Time frame: Baseline and Week 13
Change in QEEG Interhemispheric Amplitude Asymmetry (Exploratory)
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.
Time frame: Baseline and Week 13
Correlations Among Change Scores
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.
Time frame: Baseline and Week 13
Social Validity Questionnaire Total Score
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.
Time frame: Week 13
Participants' Perceptions of Training Experience and Daily-Life Changes
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.
Time frame: Week 13 to Week 15
Change in QEEG Coherence (Exploratory)
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.
Time frame: Baseline and Week 13
Change in QEEG Phase Lag (Exploratory)
Phase lag (degrees) between electrode pairs from 19-channel eyes-closed resting EEG, analyzed with NeuroGuide. Change is calculated as Week 13 minus baseline.
Time frame: Baseline and Week 13
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
Of 105 non-industry interventional studies with no phase under Self-Control, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's planned 2 months is below that.
Counting every sponsor, half of 106 studies reached it within 16 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Seoul University of Buddhism