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

• Published in: Journal of child psychology and psychiatry 2022-02, Vol.63 (2), p.187-198
• Main Authors: Purper‐Ouakil, Diane, Blasco‐Fontecilla, Hilario, Ros, Tomas, Acquaviva, Eric, Banaschewski, Tobias, Baumeister, Sarah, Bousquet, Elisa, Bussalb, Aurore, Delhaye, Marie, Delorme, Richard, Drechsler, Renate, Goujon, Allison, Häge, Alexander, Kaiser, Anna, Mayaud, Louis, Mechler, Konstantin, Menache, Caroline, Revol, Olivier, Tagwerker, Friederike, Walitza, Susanne, Werling, Anna Maria, Bioulac, Stephanie, Brandeis, Daniel
• Format: Article
• Language: English
• Subjects: Adolescent; Attention Deficit Disorder with Hyperactivity; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention Deficit Disorders; Attention deficit hyperactivity disorder; Biofeedback; Central Nervous System Stimulants; Central Nervous System Stimulants - pharmacology; Child; Child & adolescent psychiatry; Children; Control Groups; Electroencephalography; Human health and pathology; Humans; Life Sciences; Methylphenidate; Methylphenidate - pharmacology; Methylphenidate - therapeutic use; Neurofeedback; Neurofeedback - methods; Neurons and Cognition; Prospective Studies; Psychiatrics and mental health; Psychology and behavior; randomized clinical trial; Rhythm; Treatment Outcome
• ISSN: 0021-9630; 1469-7610
• DOI: 10.1111/jcpp.13462

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 13 years. 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, ClinicalTrials.gov #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.