此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年11月5日 更新者：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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

13

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 韩国
      • Seoul、韩国
        • Hong Yerin Brain Health Institute
      • Seoul、韩国
        • Magok Cultural Center
      • Seoul、韩国
        • Seoul University of Buddhism, Institute of Brain Science

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 39年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Neurofeedback

Sequential alpha-low-beta neurofeedback training, 20 sessions, twice weekly, 50 minutes per session.
设备：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.

其他名称：
  • NeuroBrain neurofeedback
无干预：Waitlist Control

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Mean Reaction Time on the Psychomotor Vigilance Test (PVT)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in PVT Lapse Rate
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in QEEG Interhemispheric Amplitude Asymmetry (Exploratory)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Seoul University of Buddhism

合作者

Magok Cultural Center

调查人员

  • 首席研究员：Yerin Hong、Seoul University of Buddhism

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月8日

初级完成 (估计的)

2026年11月7日

研究完成 (估计的)

2026年11月21日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 27004121AN01-202606-HR-090-03

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅