OBJECTIVE: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. METHOD: Unmedicated 6- to 12-year-olds with Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) ADHD were randomized to active NF versus sham-NF and to 2X versus 3X/week treatment frequency. Frequency switch was allowed after Treatment 24. RESULTS:In two school years, 39 participants were recruited and 34 (87%) completed all 40 treatments. Child/parent guesses about assigned treatment were no better than chance. At Treatment 24, 38% chose 2X/week and 62% chose 3X/week. Both active NF and sham yielded large pre-post improvement on parent ratings but NF no more than sham. CONCLUSION: Blinding appears to work, and sham does not prevent recruitment/retention. Treatment frequency of 3X/week seems preferred over 2X/week and was as effective. A large double-blind RCT is feasible and necessary to test specific NF effectiveness.
RCT Entities:
OBJECTIVE: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. METHOD: Unmedicated 6- to 12-year-olds with Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) ADHD were randomized to active NF versus sham-NF and to 2X versus 3X/week treatment frequency. Frequency switch was allowed after Treatment 24. RESULTS: In two school years, 39 participants were recruited and 34 (87%) completed all 40 treatments. Child/parent guesses about assigned treatment were no better than chance. At Treatment 24, 38% chose 2X/week and 62% chose 3X/week. Both active NF and sham yielded large pre-post improvement on parent ratings but NF no more than sham. CONCLUSION: Blinding appears to work, and sham does not prevent recruitment/retention. Treatment frequency of 3X/week seems preferred over 2X/week and was as effective. A large double-blind RCT is feasible and necessary to test specific NF effectiveness.
Authors: David Michelson; Albert J Allen; Joan Busner; Charles Casat; David Dunn; Christopher Kratochvil; Jeffrey Newcorn; F Randy Sallee; R Bart Sangal; Keith Saylor; Scott West; Douglas Kelsey; Joachim Wernicke; Nancy J Trapp; Donald Harder Journal: Am J Psychiatry Date: 2002-11 Impact factor: 18.112
Authors: Vincent J Monastra; Joel F Lubar; Michael Linden; Peter VanDeusen; George Green; William Wing; Arthur Phillips; T Nick Fenger Journal: Neuropsychology Date: 1999-07 Impact factor: 3.295
Authors: M M Lansbergen; M van Dongen-Boomsma; J K Buitelaar; D Slaats-Willemse Journal: J Neural Transm (Vienna) Date: 2010-12-17 Impact factor: 3.575
Authors: Ranganatha Sitaram; Tomas Ros; Luke Stoeckel; Sven Haller; Frank Scharnowski; Jarrod Lewis-Peacock; Nikolaus Weiskopf; Maria Laura Blefari; Mohit Rana; Ethan Oblak; Niels Birbaumer; James Sulzer Journal: Nat Rev Neurosci Date: 2016-12-22 Impact factor: 34.870
Authors: Tais S Moriyama; Guilherme Polanczyk; Arthur Caye; Tobias Banaschewski; Daniel Brandeis; Luis A Rohde Journal: Neurotherapeutics Date: 2012-07 Impact factor: 7.620