A Double-Blind, Sham-Controlled Trial Investigating Individualized Alpha Neurofeedback Plus Cognitive Training in Paediatric Brain Tumour Survivors
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- cognitive performance
研究概览
简要总结
Brief Summary of the Study:
This study is a prospective, randomized, sham-controlled, triple-blind trial investigating whether combining individualized alpha neurofeedback (NF) with cognitive training (Cogmed) can improve cognitive functioning in pediatric brain tumor survivors (PBTS), a group at risk for persistent cognitive difficulties after cancer treatment. Participants (ages 6-18) who have completed primary cancer therapy and report cognitive problems are randomly assigned to either (1) individualized alpha NF plus Cogmed or (2) sham NF plus Cogmed. Both interventions include eight one-hour sessions over four weeks, with neurofeedback (real or sham) followed by Cogmed training.
The primary outcome is cognitive performance measured by CNS Vital Signs at baseline, post-intervention, and 12-month follow-up. Secondary outcomes include attention, executive function, behavior, and quality of life (measured by SWAN, BRIEF, SDQ, and PedsQL). The study uses rigorous double-blinding and intention-to-treat analysis, with sample size planned at 40-60 participants. Results will determine if individualized alpha NF, when combined with cognitive training, yields greater cognitive and behavioral benefits than cognitive training alone in PBTS.
详细描述
This study is a prospective, randomized, sham-controlled, double-blind trial designed to evaluate whether individualized alpha neurofeedback (NF) combined with cognitive training (Cogmed) can improve cognitive functioning in pediatric brain tumor survivors (PBTS), who frequently suffer from attention, memory, and executive function difficulties following cancer treatment.
Participants:
The study plans to enroll 40-60 PBTS, aged 6 to 18, who have completed primary cancer treatment at least six months prior and report cognitive difficulties. Major exclusion criteria include severe neurological or psychiatric conditions, interfering medications, and significant sensory or motor deficits.
Design and Intervention:
Participants are randomly assigned (1:1) to one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A deterministic blinding method will be used. Each participant receives a unique de-identified ID (for example, "NFB001"), which will be processed with a custom hashing function that produces a binary value (0 or 1) with equal probability. This determines whether they receive individualized alpha feedback or sham feedback (by customised algorithm). Throughout the study, only the participant's de-identified ID is visible to researchers, site staff, and participants, thus preserving blinding.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Paediatric brain tumour survivors aged 6 to 18 years
- •Completion of primary cancer treatment (for example, surgery, chemotherapy, or radiotherapy) at least six months prior
- •Documented or reported cognitive difficulties in attention or executive functioning
- •Ability and willingness to attend scheduled sessions over four weeks
排除标准
- •- Severe neurological or psychiatric conditions (for example, uncontrolled seizures) that preclude EEG monitoring or completing computer-based training
- •Medication regimens that significantly interfere with EEG signals and cannot be safely adjusted
- •Severe sensory or motor deficits that would make training infeasible
- •Inability or unwillingness to follow study protocol
研究组 & 干预措施
Neurofeedback + Cognitive trianing
Participants will receive neurofeedback and cognitive training
干预措施: neurofeedback (Behavioral)
Neurofeedback + Cognitive trianing
Participants will receive neurofeedback and cognitive training
干预措施: Cognitive Training (Behavioral)
Sham neruofeedback + cognitve trianing
Participants will receive sham neruofeedback and cognitive training
干预措施: Cognitive Training (Behavioral)
Sham neruofeedback + cognitve trianing
Participants will receive sham neruofeedback and cognitive training
干预措施: Sham feedback (Behavioral)
结局指标
主要结局
cognitive performance
时间窗: prior to the intervention, immediate after the interventions & 6 months after the intervention
cognitive performance as measured by a neurocogntive test battery, CNS VS. the neurocognition Index (NCI) as a compostie score of various cognitive performance will be used
次要结局
- PedsQL (Pediatric Quality of Life Inventory)(prior to the intervention, immediate after the intervention & 6 months after the intervention)
- SDQ (Strengths and Difficulties Questionnaire)(prior to the intervention, immediate after the intervention 6 months after the intervention)
- Behaviour Rating Inventory of Executive Function (BRIEF)(prior to the intervention, immediate after the intervention & 6 months after the intervention)
- Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN)(prior to the intervention, immediate after the interventions & 6 months after the intervention)
研究者
Winnie Wan Yee Tso (Dr)
Clinical Associate Professor
The University of Hong Kong