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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Seoul, Южная Корея
- Hong Yerin Brain Health Institute
-
Seoul, Южная Корея
- Magok Cultural Center
-
Seoul, Южная Корея
- Seoul University of Buddhism, Institute of Brain Science
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
Другие имена:
|
|
Без вмешательства: Waitlist Control
Participants maintain usual daily activities during the study period and are offered the same neurofeedback training after study completion. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Mean Reaction Time on the Psychomotor Vigilance Test (PVT)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in PVT Lapse Rate
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in QEEG Interhemispheric Amplitude Asymmetry (Exploratory)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Yerin Hong, Seoul University of Buddhism
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 27004121AN01-202606-HR-090-03
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .