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Slow cortical potentials neurofeedback in children with ADHD: comorbidity, self-regulation and clinical outcomes 6 months after treatment in a multicenter randomized controlled trial

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Abstract

Despite sizeable short-term effects of neurofeedback (NF) therapy on attention-deficit and hyperactivity disorder (ADHD), longer-term clinical, comorbidity and self-regulation outcomes are less systematically studied. The aim of this largest NF follow-up to date was to evaluate these outcomes 6 months after NF compared to a semi-active control to disentangle specific from unspecific sustained effects. We performed a multicenter, randomized, parallel, controlled, clinical, superiority trial in five German university outpatient departments. Participants were eligible if they fulfilled DSM-IV-TR criteria for ADHD and were aged from 7 to 9 years. Participants were randomly assigned (1:1-ratio) to 25 sessions of slow cortical potential (SCP)-NF or electromyogram biofeedback (EMG-BF). Participants were not blinded, since they received instructions according to each treatment setting. Primary outcomes were parent ratings of ADHD. The trial was registered, number ISRCTN761871859. Both groups showed improvement of ADHD symptoms compared to baseline at 6-months follow-up with large effect sizes for SCP-NF (d = 1.04) and EMG-BF (d = 0.85), but without group differences. When analyzing all assessments (pre-test, post-test-1, post-test-2 and follow-up), a group-by-time interaction emerged (p = 0.0062), with SCP-NF showing stable improvement following treatment but EMG-BF showing a relapse from post-test-1 to post-test-2, and subsequent remission at follow-up. Six months after the end of treatment, improvement after SCP-NF remained large and stable. However, the lack of group differences at follow-up suggests shared specific and unspecific effects contributing to this clinical outcome. Our correlational results indicate specificity of SCP-NF for selected subscales after training, but not at follow-up.

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Acknowledgements

We thank all children and their parents who participated in the study. We thank our study nurse Brigitta Gehrig, physiotherapist Doris Brötz, for help with the EMG feedback, Christina Schwenck, Ph.D., for supervision of clinical diagnosis and recruitment, our medical and psychology students for their help in data collection and management, and neuroCare for technical support.

Funding

This study was funded by the German Research Foundation DFG HO 2503/4-1 and 2503/4-2. The funding body had no influence on the study design, collection, analysis and interpretation of data, the writing of the report, or the decision to submit the paper for publication.

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Correspondence to Pascal-M. Aggensteiner.

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AR is member of an advisory board and speakers’ bureau of Lilly, Shire, Medice and Novartis. He has received research and travel support and an educational grant from Shire. CF has received speaker’s fees from Eli Lilly and Shire. TB has served in an advisory or consultancy role for Hexal Pharma, Lilly, Medice, Novartis, Otsuka, Oxford Outcomes, PCM Scientific, Shire and Vifor Pharma. He has received conference attendance support and conference support or received speaker’s fees from Lilly, Medice, Novartis and Shire. He is/has been involved in clinical trials conducted by Lilly, Shire and Vifor Pharma. MH has served in an advisory or consultancy role for Medice and Shire, and has received conference attendance support or was paid for public speaking by Lilly, Medice, neuroConn and Shire. US has been paid for public speaking by neuroCare, the German Society for Biofeedback. DB serves as an unpaid scientific consultant of an EU-funded neurofeedback trial. The other authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Aggensteiner, PM., Brandeis, D., Millenet, S. et al. Slow cortical potentials neurofeedback in children with ADHD: comorbidity, self-regulation and clinical outcomes 6 months after treatment in a multicenter randomized controlled trial. Eur Child Adolesc Psychiatry 28, 1087–1095 (2019). https://doi.org/10.1007/s00787-018-01271-8

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  • DOI: https://doi.org/10.1007/s00787-018-01271-8

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