- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07828496
Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface
Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface - CONNECT: A Prospective Randomised Controlled Trial
The goal of this clinical trial is to determine whether a Brain-Computer Interface Neurofeedback Training (BCI-NFT) programme can improve cognitive outcomes, and whether electroencephalography (EEG)-based measures can serve as objective markers of cognitive impairment, in children and adolescents aged 7 to 21 years with acquired brain injury (ABI), including traumatic brain injury (TBI), stroke, encephalitis, brain tumour, or epilepsy.
A group of children and adolescents aged 7 to 21 years without any history of brain injury or epilepsy will also be enrolled to provide normative EEG data for comparison.
The main questions the study aims to answer are:
- Can EEG-derived measures of sustained attention, relaxation, and selective attention detect and quantify cognitive impairment in children and adolescents following ABI?
- Does a structured BCI-NFT programme improve cognitive and behavioural outcomes, including attention, memory, and executive function, compared with standard care alone?
Researchers will compare an Intervention Group, who will receive BCI-NFT in addition to standard cognitive rehabilitation, with a Waitlist-Control Group, who will initially receive standard care alone before subsequently crossing over to receive BCI-NFT. This design will allow researchers to determine whether BCI-NFT leads to greater improvements in cognitive and behavioural outcomes compared with standard care alone.
Participants in the main ABI cohort will:
- Complete behavioural assessments using the Behavior Assessment System for Children, Third Edition (BASC-3), including parent and/or teacher reports.
- Complete 12 BCI-NFT sessions over a 10-week period. Each session will last approximately 60 minutes. During each session, participants will wear a wireless EEG headset and interact with neurofeedback computer games designed to respond to their sustained attention, selective attention, and response time.
- Repeat the BASC-3 behavioural assessments at the end of the study period.
- Have undergone a recent neuropsychological assessment within the preceding 2 years and ongoing review by a neuropsychologist.
Participants in the normative EEG cohort, comprising children and adolescents without a history of brain injury or epilepsy, will attend a single study session. During this session, EEG activity will be recorded both at rest and while participants interact with a three-dimensional (3D) computer game. These recordings will provide normative EEG data against which findings from participants with ABI can be compared.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jia Hui Teo
- 전화번호: +6563926042
- 이메일: teo.jia.hui@singhealth.com.sg
연구 장소
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Singapore, 싱가포르
- 모병
- KK Women's and Children's Hospital
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연락하다:
- Jia Hui Teo, MBBS
- 전화번호: +6563926042
- 이메일: teo.jia.hui@singhealth.com.sg
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연락하다:
- Nabil
- 전화번호: 6563947254
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Normaitve cohort:
- Patients with no history of epilepsy
Inclusion Criteria:
- Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)
- Epilepsy
Exclusion Criteria:
- History of photosensitive seizures
- Diagnosis of intellectual disability
- Presence of psychotic symptoms
- Diagnosis of attention deficit and hyperactivity disorder
- Diagnosis of autism spectrum disorder
- Children on methylphenidate
- Children who are unable to cooperate with neuropsychological assessment of cognitive function
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: BCI
Intervention then standard of care
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12 sessions of BCI-NFT computer games over 10 weeks
다른 이름들:
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실험적: Usual care
Usual care followed by intervention
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12 sessions of BCI-NFT computer games over 10 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Attention Threshold
기간: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the game's adaptive attention threshold value, measured at each session, on a normalised scale between 0 to 1, where the greater value indicates greater sustained attention.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Relaxation Threshold
기간: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the game's adaptive threshold value, measured at each session, according to the normalised scale between 0 and 1, where higher value means greater sustained relaxation.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Response Time
기간: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in mean response time to in-game stimuli, measured in milliseconds, at each session.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Alpha-Lateralization Index
기간: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the alpha-lateralization index, a unitless measure derived from posterior EEG channels (P7/P8, O1/O2), ranging from -1 to +1, measured at each session.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Beta-to-Alpha Power Ratio
기간: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the ratio of EEG beta-band to alpha-band spectral power, a unitless ratio, measured at each session.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)
기간: From enrollment to 20 weeks
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Total internalising symptoms (anxiety, depression, somatisation) on BASC-3 questionnaire.
T-scores for the BASC-3 Internalizing Problems composite range from a minimum of 20 to a maximum of 120.
Higher scores indicate greater severity of mood disorder.
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From enrollment to 20 weeks
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Externalising symptoms score in Behavior Assessment System for Children, Third Edition (BASC-3)
기간: From enrollment to end of study 20 weeks
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Degree of change in total score for externalising symptoms (Hyperactivity, aggression, conduct problems) in BASC-3 questionnaire.
Raw score will be converted to T-score with range from 20 to 120.
Higher score suggests a high level of maladjustment or severe impairment
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From enrollment to end of study 20 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024/2114
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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