NCT07085494

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
27mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Aug 2025Aug 2028

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

July 17, 2025

Last Update Submit

January 23, 2026

Conditions

Brain Tumor, Primary

Outcome Measures

Primary Outcomes (1)

  • cognitive performance

    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

    prior to the intervention, immediate after the interventions & 6 months after the intervention

Secondary Outcomes (4)

  • 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

  • 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

  • Behaviour Rating Inventory of Executive Function (BRIEF)

    prior to the intervention, immediate after the intervention & 6 months after the intervention

Study Arms (2)

Neurofeedback + Cognitive trianing

EXPERIMENTAL

Participants will receive neurofeedback and cognitive training

Behavioral: neurofeedbackBehavioral: Cognitive Training

Sham neruofeedback + cognitve trianing

SHAM COMPARATOR

Participants will receive sham neruofeedback and cognitive training

Behavioral: Cognitive TrainingBehavioral: Sham feedback

Interventions

neurofeedbackBEHAVIORAL

\- 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.

Neurofeedback + Cognitive trianing
Cognitive TrainingBEHAVIORAL

\- Cogmed Training : Participants complete adaptive tasks focusing on working memory. The difficulty adjusts in real time based on performance.

Neurofeedback + Cognitive trianingSham neruofeedback + cognitve trianing
Sham feedbackBEHAVIORAL

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

Sham neruofeedback + cognitve trianing

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

NeurofeedbackCognitive Training

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Once eligible participants are enrolled in this study, they will be randomly allocated either to the neurofeedback intervention group or the sham feedback group. Participants in both groups will receive treatment/sham neurofeedback treatment at the same period. Partcipants in both groups receive cognitive training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 25, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)