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

2026년 11월 5일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

13

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

13년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

다른 이름들:
  • NeuroBrain neurofeedback
간섭 없음: Waitlist Control

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Mean Reaction Time on the Psychomotor Vigilance Test (PVT)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in PVT Lapse Rate
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Change in QEEG Interhemispheric Amplitude Asymmetry (Exploratory)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Yerin Hong, Seoul University of Buddhism

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 8일

기본 완료 (추정된)

2026년 11월 7일

연구 완료 (추정된)

2026년 11월 21일

연구 등록 날짜

최초 제출

2026년 11월 2일

QC 기준을 충족하는 최초 제출

2026년 11월 5일

처음 게시됨 (실제)

2026년 11월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 27004121AN01-202606-HR-090-03

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .