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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jia Hui Teo
- 电话号码:+6563926042
- 邮箱:teo.jia.hui@singhealth.com.sg
学习地点
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Singapore、新加坡
- 招聘中
- KK Women's and Children's Hospital
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接触:
- Jia Hui Teo, MBBS
- 电话号码:+6563926042
- 邮箱:teo.jia.hui@singhealth.com.sg
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接触:
- Nabil
- 电话号码:6563947254
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:BCI
Intervention then standard of care
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12 sessions of BCI-NFT computer games over 10 weeks
其他名称:
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实验性的:Usual care
Usual care followed by intervention
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12 sessions of BCI-NFT computer games over 10 weeks
其他名称:
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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 |
|---|---|---|
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Change in Attention Threshold
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)
大体时间: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)
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2024/2114
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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