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Neurofeedback and Cognitive Training for PBTS

NCT07085494 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • Brain Tumor, Primary

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

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085494 on ClinicalTrials.gov