Clinical trial · Interventional
Neurofeedback and Cognitive Training for PBTS
A Double-Blind, Sham-Controlled Trial Investigating Individualized Alpha Neurofeedback Plus Cognitive Training in Paediatric Brain Tumour Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Training | Behavioral | — | UNRESOLVED |
| neurofeedback | Behavioral | — | UNRESOLVED |
| Sham feedback | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neurofeedback + Cognitive trianing
- description
- Participants will receive neurofeedback and cognitive training
- interventionNames
- Behavioral: neurofeedback
- Behavioral: Cognitive Training
- type
- SHAM_COMPARATOR
- label
- Sham neruofeedback + cognitve trianing
- description
- Participants will receive sham neruofeedback and cognitive training
- interventionNames
- Behavioral: Cognitive Training
- Behavioral: Sham feedback
Primary outcomes (1)
- measure
- cognitive performance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available