CONSORT 2010 statement: extension to randomised pilot and feasibility trials.
Sandra M Eldridge, Claire L Chan, Michael J Campbell...
https://pubmed.ncbi.nlm.nih.gov/27965879Actively Recruiting
Led by Bielefeld University · Updated on 2026-05-19
40
Participants Needed
2
Research Sites
8 weeks
Total Duration
B
Bielefeld University
Lead Sponsor
P
Philipps University Marburg
Collaborating Sponsor
Researchers are evaluating two different neurofeedback training methods to help children aged 6 to 13 years with ADHD. This study aims to test the feasibility of intensive EEG-based theta-beta neurofeedback conducted in group settings during school holiday camps. It also compares a standard theta-beta ratio neurofeedback with a personalized version that adjusts training frequencies based on each child's individual alpha peak frequency, to see which better reduces ADHD symptoms over time. Participants will be randomly assigned to either the standard neurofeedback protocol with fixed frequency bands or the personalized protocol with frequencies tailored to their brain's alpha peak. Both groups will attend two 15-minute neurofeedback sessions daily for eight days, totaling 16 sessions in a camp setting. The study uses special EEG devices to monitor brain activity, providing real-time feedback during the training to encourage changes in brainwave patterns associated with attention. Throughout the study, children will be assessed before training, right after, and six months later using ADHD symptom questionnaires completed by parents, teachers, and the children themselves. Additional evaluations include brainwave measurements, attention and executive function tests, and monitoring for any adverse effects or dropout rates. The study aims to determine whether personalized neurofeedback offers more sustainable benefits compared to the standard approach.
CONDITIONS
Intensive-neurofeedback Protocol for Children With ADHD: A Proof-of-concept Study Comparing iAPF-personalized and Standard Theta-beta-ratio Training
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 days
Participants undergo neurofeedback training with either a personalized or standard theta-beta-ratio protocol. Training consists of two sessions daily over eight consecutive camp days, totaling 16 sessions.
16 neurofeedback sessions over 8 days (2 sessions daily)
Duration - Approximately 20 weeks
Participants are assessed after treatment to evaluate effects using EEG and behavioral questionnaires at multiple timepoints.
3 visits (post-measurement at week 10 and follow-up measurement at week 30)
Total: 2 locations
1
Bielefeld University
Bielefeld, Germany, 33615
Actively Recruiting
2
Philipps-University Marburg
Marburg, Germany
Actively Recruiting
L
Luisa Himmelmeier, M.Sc. Psychology
S
Sarah Lühr, M.Sc. Psychology
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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