Neurofeedback and Cognitive Training for PBTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neurofeedback, Cognitive Training, Sham feedback.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Primary. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-Blind, Sham-Controlled Trial Investigating Individualized Alpha Neurofeedback Plus Cognitive Training in Paediatric Brain Tumour Survivors
Overview
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.
Detailed description
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:
1. Individualized Alpha Neurofeedback + Cogmed (NF Group) 2. Sham Neurofeedback + Cogmed (Sham Group) Both groups participate in eight one-hour sessions over four weeks. Each session includes 30 minutes of neurofeedback (either real, based on each participant's individualized alpha EEG band, or sham, based on pre-recorded EEG data but with identical procedures) followed by 30 minutes of Cogmed cognitive training (adaptive, computerized working memory tasks).
Blinding:
The study is double-blind: both participants and outcome assessors are blinded to group allocation. The neurofeedback software automatically delivers either real or sham feedback according to assignment, maintaining blinding for all involved.
Objectives and Outcome Measures:
The primary objective is to determine whether the combined individualized alpha NF and Cogmed intervention leads to superior improvements in cognitive functioning, measured by CNS Vital Signs, compared to sham NF plus Cogmed. Assessments occur at baseline, immediately post-intervention, and at 12-month follow-up.
Secondary objectives include evaluating changes in attention, executive function, behavior, and quality of life, using validated tools such as the SWAN, BRIEF, SDQ, and PedsQL. The study will also examine neurophysiological changes (qEEG markers) and their relationship to cognitive and behavioral outcomes.
Data Analysis:
Primary and secondary outcomes will be analyzed using mixed linear models to assess group-by-time interactions. An intention-to-treat approach will include all randomized participants, with appropriate methods for handling missing data.
Significance:
This study will clarify whether adding individualized alpha neurofeedback to cognitive training offers additional cognitive and behavioral benefits for pediatric brain tumor survivors, compared to cognitive training alone, using a rigorous double-blind, sham-controlled methodology with a planned sample size of 40-60 participants.
Interventions
- Behavioral neurofeedback
\- Neurofeedback Training : Feedback is based on individualized alpha band power. Participants see a game-like display (for instance, a plane) that reflects their alpha activity. Excessive EMG (muscle tension) causes performance drops, encouraging relaxation. - Behavioral Cognitive Training
\- Cogmed Training : Participants complete adaptive tasks focusing on working memory. The difficulty adjusts in real time based on performance. - Behavioral Sham feedback
The sham neurofeedback protocol was identical to the verum neurofeedback protocol except that the animation (horizontal plane movement) was based on the EEG results of another participant. EMG-based feedback will still be provided for the sham condition
Primary outcome measures
- cognitive performance [Time frame: prior to the intervention, immediate after the interventions & 6 months after the intervention]
Secondary outcome measures (4)
- PedsQL (Pediatric Quality of Life Inventory) [Time frame: prior to the intervention, immediate after the intervention & 6 months after the intervention]
- SDQ (Strengths and Difficulties Questionnaire) [Time frame: 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) [Time frame: prior to the intervention, immediate after the interventions & 6 months after the intervention]
- Behaviour Rating Inventory of Executive Function (BRIEF) [Time frame: prior to the intervention, immediate after the intervention & 6 months after the intervention]
Eligibility criteria
Inclusion criteria
- \- 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
Exclusion criteria
- \- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Hong Kong Children's Hospital — Hong Kong
Identifiers
NCT: NCT07085494 · HKU_PBTS_NF_CT