A Double-Blind, Sham-Controlled Trial Investigating Individualized Alpha Neurofeedback Plus Cognitive Training in Paediatric Brain Tumour Survivors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07085494
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Hong Kong
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Primary

Additional Details

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.

Arms & Interventions

Arms

Experimental: Neurofeedback + Cognitive trianing

Participants will receive neurofeedback and cognitive training

Sham Comparator: Sham neruofeedback + cognitve trianing

Participants will receive sham neruofeedback and cognitive training

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Winnie Tso, MBBS

[email protected]

60880833

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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