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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jia Hui Teo
- 電話番号：+6563926042
- メール：teo.jia.hui@singhealth.com.sg
研究場所
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Singapore、シンガポール
- 募集
- KK Women's and Children's Hospital
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コンタクト：
- Jia Hui Teo, MBBS
- 電話番号：+6563926042
- メール：teo.jia.hui@singhealth.com.sg
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コンタクト：
- Nabil
- 電話番号：6563947254
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：BCI
Intervention then standard of care
|
12 sessions of BCI-NFT computer games over 10 weeks
他の名前：
|
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実験的：Usual care
Usual care followed by intervention
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12 sessions of BCI-NFT computer games over 10 weeks
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Attention Threshold
時間枠：Baseline (Session 1) to final session (Session 12), over 10 weeks
|
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.
|
Baseline (Session 1) to final session (Session 12), over 10 weeks
|
|
Change in Relaxation Threshold
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline (Session 1) to final session (Session 12), over 10 weeks
|
Change in the ratio of EEG beta-band to alpha-band spectral power, a unitless ratio, measured at each session.
|
Baseline (Session 1) to final session (Session 12), over 10 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)
時間枠：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)
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024/2114
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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