Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial.

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Publisher: Wiley Subscription Services, Inc.
Document Type: Report; Brief article
Length: 363 words

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Keywords: Attention-deficit hyperactivity disorder; neurofeedback; methylphenidate; randomized clinical trial Background Neurofeedback is considered a promising intervention for the treatment of attention-deficit hyperactivity disorder (ADHD). NEWROFEED is a prospective, multicentre, randomized (3:2), reference drug-controlled trial in children with ADHD aged between 7 and 13years. The main objective of NEWROFEED was to demonstrate the noninferiority of personalized at-home neurofeedback (NF) training versus methylphenidate in the treatment of children with ADHD. Methods The NF group (n=111) underwent eight visits and two treatment phases of 16 to 20 at-home sessions with down-training of the theta/beta ratio (TBR) for children with high TBR and enhancing the sensorimotor rhythm (SMR) for the others. The control group (n=67) received optimally titrated long-acting methylphenidate. The primary endpoint was the change between baseline and endpoint in the Clinician ADHD-RS-IV total score in the per-protocol population (90 NF/59 controls). Trial registration: US National Institute of Health, #NCT02778360. Results Our study failed to demonstrate noninferiority of NF versus methylphenidate (mean between-group difference 8.09 90% CI [8.09; 10.56]). However, both treatment groups showed significant pre-post improvements in core ADHD symptoms and in a broader range of problems. Reduction in the Clinician ADHD-RS-IV total score between baseline and final visit (D90) was 26.7% (SMD=0.89) in the NF and 46.9% (SMD=2.03) in the control group. NF effects increased whereas those of methylphenidate were stable between intermediate and final visit. Conclusions Based on clinicians' reports, the effects of at-home NF were inferior to those of methylphenidate as a stand-alone treatment. Article Note: Conflict of interest statement: See Acknowledgements for full disclosures. CAPTION(S): Appendix S1. Supplements to the Methods section. Appendix S2. CRED-nf checklist summary output. Appendix S3. Details about the study population and data sets analysed. Appendix S4. Country effects. Table S1. Country Effects - change from baseline at D90. Table S2. Secondary variables - change from baseline at D90. Table S3. Adverse events occurring in 5% of patients. Byline: Diane Purper-Ouakil, Hilario Blasco-Fontecilla, Tomas Ros, Eric Acquaviva, Tobias Banaschewski, Sarah Baumeister, Elisa Bousquet, Aurore Bussalb, Marie Delhaye, Richard Delorme, Renate Drechsler, Allison Goujon, Alexander Häge, Anna Kaiser, Louis Mayaud, Konstantin Mechler, Caroline Menache, Olivier Revol, Friederike Tagwerker, Susanne Walitza, Anna Maria Werling, Stephanie Bioulac, Daniel Brandeis

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Gale Document Number: GALE|A693538468