Intensive-neurofeedback Protocol for Children With ADHD: A Proof-of-concept Study Comparing iAPF-personalized and Standard Theta-beta-ratio Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adverse effects
研究概览
简要总结
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)
详细描述
The study investigates the effectiveness of two NF approaches within a "school-holiday-camp"-setting. NF is a learning method based on neural plasticity, where specific EEG frequency bands are fed back in real-time. Participants will be randomly assigned to one of two conditions:
- Standard-NF training targeting a reduction of the TBR with fixed reward frequencies for the entire group.
- iAPF-TBR NF training targeting a reduction of the TBR with reward frequencies individually adjusted based on the child's pre-measured iAPF.
The training includes two sessions daily over eight camp days (a total of 16 sessions). While a small effect size (d = .2) would be expected for the comparison of iAPF-TBR NF and standard TBR NF requiring a total sample of N = 620 α= .05, 1-β = .8, G*Power; Faul et al., 2007), the present study is designed as a preliminary proof-of-concept study including an adopted target sample size. Therefore, the target sample size is set at N = 40 participants (n = 20 per arm). This sample size is sufficient to detect a medium to large effect (d = .7) with α= .10 and 1-β = .7 using one-tailed testing. This directional testing is justified by the theoretical advantage of personalized iAPF-TBR over the standard-TBR NF. The results of this pilot study will serve as essential preliminary evidence to justify the scaling of the protocol in a fully powered RCT.
The effects will be evaluated at the EEG, parent-, teacher- and self-report questionnaires, and behavioral (CPT) levels. The main objective is to determine whether the personalized NF protocol leads to superior and more sustainable effects.
Baseline frequency bands: Prior to each neurofeedback session, a one-minute resting-state EEG baseline is recorded to establish individual gain thresholds for theta and beta power. To control for non-cortical influences such as EMG artefacts, Power in frequency band 20-40 Hz is additionally required to be below a baseline threshold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 T
- •These are recorded as control variables and are not exclusion criteria. The medication intake was kept constant during the NF training.
研究组 & 干预措施
iAPF-TBR-NF
干预措施: iAPF -TBR-NF (Behavioral)
Standard-TBR-NF
干预措施: Standard TBR-NF (Behavioral)
结局指标
主要结局
Adverse effects
时间窗: 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
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.
Drop-Out rate
时间窗: 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
The rate of participants discontinuing the neurofeedback training and study participation is measured. The drop-out rate is one indicator (acceptability) of feasibility.
Number of included segments
时间窗: During week 5 and 6 after each neurofeedback session (intervention)
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.
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)
时间窗: Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30
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.
Child Behavior Checklist 6-18/R (CBCL; Döpfner et al., 2014)
时间窗: Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30
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.
Teacher Report Form 6-18/R (TRF; Döpfner et al., 2014)
时间窗: Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30
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.
Youth Self Report 11-18/R (YSR, Döpfner et al., 2014)
时间窗: Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30
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.
Change in central theta and beta activity
时间窗: Baseline at week 1, post-measurement at week 10, follow-up-measurement at week 30
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)
次要结局
- 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)