Intensive-neurofeedback Protocol for Children With ADHD: A Proof-of-concept Study Comparing iAPF-personalized and Standard Theta-beta-ratio Training

NCT07595783 | Recruiting

• 1 other identifier: NF-2024-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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)

Conditions

ADHD; Inattention; Hyperactivity; Impulsivity; Executive Dysfunction

Keywords

EEG-neurofeedback; ADHD; children

Outcome Measures

Primary Outcomes (8)

• Adverse effects

  Effects that lead to symptom enhancements, as well as negative side effects of the neurofeedback training, are considered as adverse effects. The absence of adverse effects is one indicator of feasibility.

  Baseline at week 1, during week 5 and 6 after each neurofeedback session (intervention), post-measurement at week 10, follow-up-measurement at week 30

• Drop-Out rate

  The rate of participants discontinuing the neurofeedback training and study participation is measured. The drop-out rate is one indicator (acceptability) of feasibility.

  Baseline at week 1, during week 5 and 6 after each neurofeedback session (intervention), post-measurement at week 10, follow-up-measurement at week 30

• Number of included segments

  The continuous EEG recorded during active neurofeedback training is scanned offline for artefacts, and the proportion of artefact-free segments is considered as an indicator of data quality (and thus feasibility) during neurofeedback training. Higher numbers of included segments indicate a larger amount of artifact-free data, suggesting higher data quality.

  During week 5 and 6 after each neurofeedback session (intervention)

• Diagnostic system for mental disorders according to ICD-10 and DSM-5 for children and adolescents - III External report form ADHD specific (DISYPS-III FBB-ADHS; Döpfner et al., 2017)

  Parent- and teacher-reported total score of ADHD symptoms, inattention, hyperactivity-impulsivity. It also captures functional impairment and distress. These can be used to determine whether or not the criteria for an ADHD diagnosis are met. In the analysis of this study, the scales for the three cardinal symptoms: inattention, hyperactivity-impulsivity and the total ADHD symptom score will be focussed. The subscales consist of 9 items (inattention) and 11 items (hyperactivity-impulsivity), which are rated between the categories 0 = "not accurate at all" and 3 = "especially accurate". Point-values between 0 and 27 can be reached for inattention and between 0 and 33 for hyperactivity/impulsivity. The total ADHD score uses the 20 items of both subscales and though can reach point-values between 0 and 60. The scales' scores show an increase in severity of symptoms (inattention, hyperactivity/impulsivity and total ADHD) as the point-values increase.

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

• Child Behavior Checklist 6-18/R (CBCL; Döpfner et al., 2014)

  Parent report questionnaire for assessing attention problems, with help of the two symptom groups: inattention and impulsivity/hyperactivity. The analyses are carried out primarily with the total score of the scale. The subscale attention problems contains 10 items with answer categories ranging from 0 = "not correct" to 2 = "absolutely correct", resulting in point-values ranging from 0 to 20. Because a separate previous study with the same questionnaires showed particular predictivity in the Child Behavior Checklist with certain 7 items, the analyses are calculated again with the shortened version on inattention (point-values: 0-14). The scales' scores show an increase in severity of inattention symptoms as the point-values increase.

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

• Teacher Report Form 6-18/R (TRF; Döpfner et al., 2014)

  Teacher Report questionnaire investigating attention problems divided into inattention and hyperactivity/impulsivity. The analyses are carried out primarily with the total score of the scale. For assessing inattention, the scale uses 14 items with answer categories ranging from 0 = "not correct" to 2 = "absolutely correct", resulting in point-values ranging from 0 to 28. Hyperactivity/Impulsivity is assessed with 12 items and the same answer categories, resulting in possible point-values between 0 and 24. Because a separate previous study with the same questionnaires showed particular predictivity in TRF with certain 7 items, the analyses are calculated again with the shortened version on inattention (point-values: 0-14). The scales' scores show an increase in severity of inattention symptoms as the point-values increase.

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

• Youth Self Report 11-18/R (YSR, Döpfner et al., 2014)

  Self-report for children assessing attention problems divided into inattention and impulsivity/hyperactivity. The analyses are carried out primarily with the total score of the scale. The YSR will be used for children upon the age of 6 years, as the previous study showed usability for children under the age of 11 years. The subscale attention problems contains 9 items with answer categories ranging from 0 = "not correct" to 2 = "absolutely correct", resulting in point-values ranging from 0 to 18. Because a separate previous study with the same questionnaires showed particular predictivity in YSR with certain 7 items, the analyses are calculated again with the shortened version on inattention (point-values: 0-14). The scales' scores show an increase in severity of inattention symptoms as the point-values increase.

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

• Change in central theta and beta activity

  Quantitative EEG: 10 min. (5 min. eyes opened, 5 min. eyes closed): * Measured frequency bands: theta, alpha, beta, gamma * Aimed for data analysis with the Brain Vision Analyzer software, version 2.3.0 (Brain Products GmbH, Germany): theta and beta with at least 30 segments (2s each) of the first three minutes Electrode positions: Fpz, Fz, Cz, Pz, Oz, A1 and A2, VEOG (electrodes placed above and below the left eye), HEOG (electrodes placed at the outer canthi)

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

Secondary Outcomes (2)

• Behavior Rating Inventory of Executive Function (BRIEF; Drechsler et al., 2013)

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

• Continuous Performance Test (CPT, Knye et al., 2003)

  Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30

Study Arms (2)

iAPF-TBR-NF

EXPERIMENTAL

Behavioral: iAPF -TBR-NF

Standard-TBR-NF

ACTIVE COMPARATOR

Behavioral: Standard TBR-NF

Interventions

Standard TBR-NF BEHAVIORAL

Training is based on the classic Theta-Beta-Ratio protocol, where the reward frequencies are fixed for the entire training group (Hao et al., 2022): Frequency bands with fixed division: Theta 4 - 8 Hz Alpha 8 - 13 Hz Beta 13 - 30 Hz Gamma 30 - 45 Hz * Upgrade Beta Frequencies: 13 - 30 Hz * Downgrade Theta Frequencies: 4 - 8 Hz * Aim: Reduce Theta-Beta Ratio * 10-20-electrode positions: Cz with reference and ground electrodes at A1 and A2 * Duration: 15 min.

Standard-TBR-NF

iAPF -TBR-NF BEHAVIORAL

Reward frequencies are adjusted based on the child's iAPF to create a customized training protocol: Calculation of the frequency bands using T1-iAPF (Hao et al., 2022): Frequency bands with individual division: Theta 4 - 0.8 \* iAPF Hz Alpha 0.8 \* iAPF - 1.3 \* iAPF Hz Beta 1.3 \* iAPF - 3.0 \* iAPF Hz Gamma 3.0 \* iAPF - 45 Hz * Upgrade individually calculated beta frequencies * Downgrade individually calculated theta frequencies * Aim: Reduce Theta-Beta Ratio * 10-20-electrode positions: Cz with reference and ground electrodes at A1 and A2 * Duration: 15 min.

iAPF-TBR-NF

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bielefeld University: lead
• Philipps University Marburg: collaborator

Study Sites (2)

Bielefeld University

Bielefeld, 33615, Germany

RECRUITING

Philipps-University Marburg

Marburg, Germany

RECRUITING

Related Publications (7)

• Drechsler, R., & Steinhausen, H. C. E. (2013). Verhaltensinventar zur Beurteilung exekutiver Funktionen: Deutschsprachige Adaptation des Behavior Rating Inventory of Executive Function: BRIEF.

  BACKGROUND

• Döpfner, M., Plück, J. & Kinnen, C. (2014). Deutsche Schulalter-Formen der Child Behavior Checklist von Thomas M. Achenbach. Hogrefe.

  BACKGROUND

• Knye, M., Roth, N., Westhus, W. & Heine, A. (2003). Continuos Performance Test. Hogrefe.

  BACKGROUND

• Döpfner, M., & Görtz-Dorten, A. (2017). Diagnostik-System für psychische Störungen nach ICD-10 und DSM-5 für Kinder und Jugendliche-III (DISYPS-III) (3. Aufl.). Hogrefe.

  BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.

  PMID: 27965879 BACKGROUND

• Hao Z, He C, Ziqian Y, Haotian L, Xiaoli L. Neurofeedback training for children with ADHD using individual beta rhythm. Cogn Neurodyn. 2022 Dec;16(6):1323-1333. doi: 10.1007/s11571-022-09798-y. Epub 2022 Apr 1.

  PMID: 36408061 BACKGROUND

• Himmelmeier L, Waltereit R, Werheid K. Multi-method ADHD diagnostics in children: CBCL and TRF lead the way. Front Psychiatry. 2025 Nov 17;16:1668149. doi: 10.3389/fpsyt.2025.1668149. eCollection 2025.

  PMID: 41334079 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Impulsive Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Katja Werheid, Prof. Dr.

  Bielefeld University

  STUDY CHAIR

• Björn Albrecht, Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

• Luisa Himmelmeier, M.Sc. Psychology

  Bielefeld University

  PRINCIPAL INVESTIGATOR

• Mira-Lynn Chavanon, Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

• Hanna Christiansen, Prof. Dr.

  Philipps University Marburg

  STUDY CHAIR

Central Study Contacts

Luisa Himmelmeier, M.Sc. Psychology

CONTACT

+49 (0) 521 106 67534; Lhimmelmeier@uni-bielefeld.de

Sarah Lühr, M.Sc. Psychology

CONTACT

+49 (0) 521 106 4513; sarah.luehr@uni-bielefeld.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The evaluation of the parent-, teacher- and self-report questionnaires and the CPT and NF is carried out by personnel who are unaware of the group assignment (standard vs. personalized).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Description: 2-arm, randomized controlled trial (RCT). Assignment to the two experimental conditions (personalized-NF vs. standard-NF) is randomized. There are three assessment points: T1 (Pre, 4 weeks pre-camp), T2 (Post, maximum 4 weeks after the camp), T3 (Follow-Up, 6 months post-camp)

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 19, 2026
• Study Start: July 9, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)