Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT07085494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-Blind, Sham-Controlled Trial Investigating Individualized Alpha Neurofeedback Plus Cognitive Training in Paediatric Brain Tumour Survivors
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
A Double-Blind, Sham-Controlled Trial Investigating Individualized Alpha Neurofeedback Plus Cognitive Training in Paediatric Brain Tumour Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: