Neurofeedback Training for Adolescents and Young Adults With Borderline Intellectual Functioning (NFB-BIF)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Seoul、韓国
- Hong Yerin Brain Health Institute
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Seoul、韓国
- Magok Cultural Center
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Seoul、韓国
- Seoul University of Buddhism, Institute of Brain Science
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Neurofeedback
Sequential alpha-low-beta neurofeedback training, 20 sessions, twice weekly, 50 minutes per session. |
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.
他の名前：
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介入なし：Waitlist Control
Participants maintain usual daily activities during the study period and are offered the same neurofeedback training after study completion. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Mean Reaction Time on the Psychomotor Vigilance Test (PVT)
時間枠：Baseline and Week 13
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in PVT Lapse Rate
時間枠：Baseline and Week 13
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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
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Change in Brief Symptom Inventory-18 (BSI-18) Total and Subscale Scores
時間枠：Baseline and Week 13
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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
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Change in Korean Social Skills Rating System for College Students (K-SSRS) Total and Subscale Scores
時間枠：Baseline and Week 13
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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
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Change in QEEG Relative Power (Theta, Alpha, Low-Beta)
時間枠：Baseline and Week 13
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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
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Change in QEEG Theta/Beta Ratio
時間枠：Baseline and Week 13
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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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Change in QEEG Interhemispheric Amplitude Asymmetry (Exploratory)
時間枠：Baseline and Week 13
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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
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Correlations Among Change Scores
時間枠：Baseline and Week 13
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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
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Social Validity Questionnaire Total Score
時間枠：Week 13
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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
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Participants' Perceptions of Training Experience and Daily-Life Changes
時間枠：Week 13 to Week 15
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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
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Change in QEEG Coherence (Exploratory)
時間枠：Baseline and Week 13
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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
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Change in QEEG Phase Lag (Exploratory)
時間枠：Baseline and Week 13
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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
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協力者と研究者
捜査官
- 主任研究者：Yerin Hong、Seoul University of Buddhism
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 27004121AN01-202606-HR-090-03
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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