Cynthia Kerson1. 1. ISNR Research Foundation, San Rafael, CA 94901, USA. executivedirector@isnr-researchfoundation.org
Abstract
OBJECTIVE: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large benefit for NF, a well-blinded, sham-controlled RCT is needed to differentiate specific from nonspecific effects. METHOD: Experts in NF, ADHD, clinical trials, and statistics collaborated to design a double-blind multisite RCT. RESULTS/ CONCLUSION: At four sites, 180 children aged 7 to 10 years with rigorously diagnosed ADHD and TBR ≥ 5 will be randomized to active TBR-NF versus sham NF of equal duration, intensity, and appearance. Sham, utilizing prerecorded EEGs with participant artifacts superimposed, will keep participants and staff blind. Treatment fidelity will be trained/monitored by acknowledged NF leaders. Multidomain assessments before, during, and after treatment (follow-up to 2 years) will also include tests of blinding and sham inertness.
RCT Entities:
OBJECTIVE: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large benefit for NF, a well-blinded, sham-controlled RCT is needed to differentiate specific from nonspecific effects. METHOD: Experts in NF, ADHD, clinical trials, and statistics collaborated to design a double-blind multisite RCT. RESULTS/ CONCLUSION: At four sites, 180 children aged 7 to 10 years with rigorously diagnosed ADHD and TBR ≥ 5 will be randomized to active TBR-NF versus sham NF of equal duration, intensity, and appearance. Sham, utilizing prerecorded EEGs with participant artifacts superimposed, will keep participants and staff blind. Treatment fidelity will be trained/monitored by acknowledged NF leaders. Multidomain assessments before, during, and after treatment (follow-up to 2 years) will also include tests of blinding and sham inertness.
Authors: Madelon A Vollebregt; Martine van Dongen-Boomsma; Dorine Slaats-Willemse; Jan K Buitelaar Journal: Front Hum Neurosci Date: 2014-05-15 Impact factor: 3.169
Authors: Ute Strehl; Pascal Aggensteiner; Daniel Wachtlin; Daniel Brandeis; Björn Albrecht; Maria Arana; Christiane Bach; Tobias Banaschewski; Thorsten Bogen; Andrea Flaig-Röhr; Christine M Freitag; Yvonne Fuchsenberger; Stephanie Gest; Holger Gevensleben; Laura Herde; Sarah Hohmann; Tanja Legenbauer; Anna-Maria Marx; Sabina Millenet; Benjamin Pniewski; Aribert Rothenberger; Christian Ruckes; Sonja Wörz; Martin Holtmann Journal: Front Hum Neurosci Date: 2017-03-31 Impact factor: 3.169