NCT07595783 Intensive-neurofeedback Protocol for Children With ADHD: A Proof-of-concept Study Comparing iAPF-personalized and Standard Theta-beta-ratio Training
| NCT ID | NCT07595783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bielefeld University |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-07-09 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The first aim of this clinical trial is to test the feasibility and signal validity of a new approach to neurofeedback training (NF) using intensive EEG-based theta-beta NF for children with ADHD in the context of NF camps during school holidays. The second aim is to compare the efficacy of two neurofeedback protocols in reducing ADHD symptoms. Previous study results highlight that children with ADHD frequently show increased Theta-Beta-Ratios (TBR) in the qEEG, probably associated with attention difficulties, which may be ameliorated following neurofeedback training. However, the current state of research shows heterogenous findings regarding the efficacy of standard TBR NF for children with ADHD. Further study results suggest that personalized NF training protocols, based on the individual alpha peak frequency (iAPF), may be more effective in reducing ADHD symptoms than standardized ones. Therefore, in this proof-of-concept study of children with ADHD a standard TBR NF protocol is compared with an iAPF-personalized TBR NF (iAPF-TBR NF) protocol (based on the previously obtained iAPF). The study is designed as a randomized controlled intervention trial (RCT) with three assessment points (pre \[T1\], post \[T2\] and 6-month follow-up \[T3\]). Primary endpoints include the reduction of ADHD symptoms assessed by parent-, teacher- and self-report questionnaires. Furthermore, it is hypothesized that NF training is associated with better performance in a sustained attention and executive function test and a reduced TBR in qEEG, particularly following iAPF-TBR NF. The main questions are: * Is it feasible to train groups of up to 12 children with two sessions NF per day for an eight-day-period during their school holidays? * Does iAPF-TBR NF provide a valid neuromodulatory signal compared to the standard-TBR-NF protocol? Do the frequency boundaries demonstrate spectral stability across the 16 training sessions? * Does the personalized iAPF-TBR NF training reduce ADHD symptoms measured immediately after the training more than standard-TBR-NF training? (comparison T2-T1) * Does the personalized iAPF-TBR NF training reduce ADHD symptoms measured 6 months after the NF training more than standard TBR-NF training? (comparison T3-T1) * Does the reduction in ADHD symptoms measured immediately after the NF-training persist until the 6-month follow-up? Do possible differences between iAPF-TBR NF training and standard TBR NF training remain? (comparison T3-T2) Post-hoc analyses of the courses are carried out. In addition, selectivity analyses will be carried out for clinical subgroups (e.g. different ADHD profiles)
Eligibility Criteria
Inclusion Criteria: * Children aged 6-13 years. Confirmed ADHD diagnosis (ICD 10: F90.0, F90.1, or F98.8) * German-speaking children with normal or corrected vision. Exclusion Criteria: * Children with neurological disorders (e.g., Epilepsy) * Children without an ADHD diagnosis * Caregivers with inability to provide informed consent or complete questionnaires * Participation in neurofeedback that was conducted in the year prior to the intended participation or is still ongoing. The intake of medication or psychotherapeutic treatments and ICD-10 diagnosis are queried at T1, T2 and T3. These are recorded as control variables and are not exclusion criteria. The medication intake was kept constant during the NF training.
Contact & Investigator
Katja Werheid, Prof. Dr.
STUDY CHAIR
Bielefeld University
Frequently Asked Questions
Who can join the NCT07595783 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 13 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07595783 currently recruiting?
Yes, NCT07595783 is actively recruiting participants. Contact the research team at Lhimmelmeier@uni-bielefeld.de for enrollment information.
Where is the NCT07595783 trial being conducted?
This trial is being conducted at Bielefeld, Germany, Marburg, Germany.
Who is sponsoring the NCT07595783 clinical trial?
NCT07595783 is sponsored by Bielefeld University. The principal investigator is Katja Werheid, Prof. Dr. at Bielefeld University. The trial plans to enroll 40 participants.