Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up - 23/06/21
The Neurofeedback Collaborative Group
, Martijn Arns, PhD, Justin Barterian, PhD, Rachel Bergman, BA, Sarah Black, PhD, C. Keith Conners, PhD (deceased), Shea Connor, BS, Sudeshna Dasgupta, MD, Roger deBeus, PhD, Teryll Higgins, MA, Laurence Hirshberg, PhD, Jill A. Hollway, PhD, Cynthia Kerson, PhD, Howard Lightstone, BS, Nicholas Lofthouse, PhD, Joel Lubar, PhD, Keith McBurnett, PhD, Vincent Monastra, PhD, Kristin Buchan-Page, BA, Xueliang (Jeff) Pan, PhD, Robert Rice, PhD, Michelle E. Roley-Roberts, PhD, Rachel Rhodes, MLAS, Constance Schrader, PhD, Yubo (Jeremy) Tan, MS, MBBS, Craig E. Williams, MDAbstract |
Objective |
To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback [NF]) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.
Method |
In a 2-site double-blind randomized clinical trial, 144 children aged 7 to 10 years with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR) ≥4.5 were randomized 3:2 to deliberate TBR downtraining versus a control of equal duration, intensity, and appearance. Two early dropouts left 142 children for modified intent-to-treat analysis. The control used prerecorded electroencephalograms with the participant’s artifacts superimposed. Treatment was programmed via Internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists and 93.2% by NF expert monitor. The primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because the expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated.
Results |
Blinding was excellent. Although both groups showed significant improvement (p < .001, d = 1.5) in parent/teacher-rated inattention from baseline to treatment end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d = 0.01, p = .965 at treatment end; d = 0.23, p = .412 at 13-month follow-up). Responders (Clinical Global Impression−Improvement [CGI-I] = 1−2) were 61% of NF and 54% of controls (p = .36). Adverse events were distributed proportionally between treatments. The 13-month follow-up found nonsignificant improvement from treatment end for NF (d = 0.1), with mild deterioration for controls (d = −0.07). NF required significantly less medication at follow-up (p = .012).
Conclusion |
This study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.
Clinical trial registration information |
Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; clinicaltrials.gov/; NCT02251743.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : ADHD, neurofeedback, clinical trials, double-blind, attention-deficit
Plan
| This research was supported by National Institute of Mental Health (NIMH) grant #R01-MH100144 by Ohio State University College of Medicine Endowment and by a Clinical and Translational Science award 8UL18TR000090-05 from the National Center for Translational Sciences. |
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| Preliminary results were presented at the American Academy of Child and Adolescent Psychiatry 65th Annual Meeting; October 22−27, 2018; Seattle, Washington. Full results were presented at the American Academy of Child and Adolescent Psychiatry 66th Annual Meeting; October 14−19, 2019; Chicago, Illinois. |
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| Dr. Pan, Mr. Tan, and Helena C. Kraemer, PhD, served as the statistical experts for this research. |
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| Author Contributions |
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| Conceptualization: Arnold, Arns, deBeus, Hirshberg, Hollway, Kerson, Lubar, McBurnett, Monastra |
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| Data curation: Arns, deBeus, Lightstone, Monastra, Buchan-Page, Pan, Rice, Tan |
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| Formal analysis: Arnold, Arns, Black, Conners, Dasgupta, deBeus, Hollway, Kerson, Lofthouse, Monastra, Buchan-Page, Pan, Rice, Roley-Roberts, Rhodes, Schrader, Tan, Williams |
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| Fundingacquisition: Arnold |
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| Investigation: Arnold, Black, Connor, Dasgupta, deBeus, Kerson, McBurnett, Monastra, Pan, Roley-Roberts |
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| Methodology: Arnold, Arns, Barterian, Bergman, Black, Conners, Connor, Dasgupta, deBeus, Higgins, Hirshberg, Hollway, Kerson, Lofthouse, Lubar, Monastra |
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| Project administration: Arnold, Barterian, Bergman, Connor, deBeus, Higgins, Hollway, Kerson, Monastra, Buchan-Page, Roley-Roberts |
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| Resources: Arnold, Connor, deBeus, Kerson, Lightstone, Monastra, Buchan-Page, Pan, Tan |
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| Software: Lightstone |
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| Supervision: Arnold, Barterian, Black, deBeus, Hollway, Kerson, Rhodes, Schrader, Williams |
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| Validation: Arnold, Arns, Barterian, Black, deBeus, Hollway, Kerson, Monastra, Buchan-Page, Rhodes, Williams |
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| Visualization: Arnold, Arns, Connor, deBeus, Pan, Tan |
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| Writing – original draft: Arnold, Arns, deBeus |
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| Writing – review and editing: Kerson, Monastra, Pan, Roley-Roberts |
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| ORCID |
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| L. Eugene Arnold, MD, MEd: 0000-0002-0886-0692 |
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| Martijn Arns, PhD: 0000-0002-0610-7613 |
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| Justin Barterian, PhD: 0000-0001-8392-8979 |
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| Rachel Bergman, BA: 0000-0002-9706-4726 |
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| Sarah Black, PhD: 0000-0002-8090-1217 |
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| Roger deBeus, PhD: 0000-0001-9426-2690 |
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| Teryll Higgins, MA: 0000-0001-5116-1398 |
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| Jill A. Hollway, PhD: 0000-0001-6796-1947 |
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| Cynthia Kerson, PhD: 0000-0001-5861-1443 |
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| Howard Lightstone, BS: 0000-0001-9711-1257 |
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| Keith McBurnett, PhD: 0000-0001-7327-2435 |
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| Vincent Monastra, PhD: https://orcid.org/0000-0003-2000-4714 |
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| Kristin Buchan-Page, BA: https://orcid.org/0000-0003-0094-2789 |
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| Xueliang (Jeff) Pan, PhD: 0000-0002-2342-3212 |
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| Robert Rice, PhD: 0000-0003-3285-5567 |
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| Michelle E. Roley-Roberts, PhD: 0000-0002-9269-418X |
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| Constance Schrader, PhD: 0000-0001-6905-2026 |
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| Yubo (Jeremy) Tan, MS, MBBS: 0000-0001-9592-7658 |
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| Craig E. Williams, MD: https://orcid.org/0000-0002-5955-2147 |
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| Authors of this article comprise the Neurofeedback Collaborative Group, in alphabetical order: L. Eugene Arnold, MD, MEd, Martijn Arns, PhD, Justin Barterian, PhD, Rachel Bergman, BA, Sarah Black, PhD, C. Keith Conners, PhD (deceased), Shea Connor, BS, Sudeshna Dasgupta, MD, Roger deBeus, PhD, Teryll Higgins, MA, Laurence Hirshberg, PhD, Jill A. Hollway, PhD, Cynthia Kerson, PhD, Howard Lightstone, BS, Nicholas Lofthouse, PhD, Joel Lubar, PhD, Keith McBurnett, PhD, Vincent Monastra, PhD, Kristin Buchan-Page, BA, Xueliang (Jeff) Pan, PhD, Robert Rice, PhD, Michelle E. Roley-Roberts, PhD, Rachel Rhodes, MLAS, Constance Schrader, PhD, Yubo (Jeremy) Tan, MS, MBBS, Craig E. Williams, MD. |
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| Disclosure: Dr. Arnold has received research funding from Shire, Supernus, Otsuka, Roche/Genentech, and YoungLiving, has consulted with Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), Pfizer, and Waypoint, and has been on advisory boards for Ironshore, Novartis, Otsuka, Pfizer, Roche, and Shire (a Takeda company). Dr. Arns is unpaid research director of the Brainclinics Foundation, a minority shareholder in neuroCare Group (Munich, Germany); Brainclinics Foundation has received research funding from NIMH, Brain Resource (Sydney, Australia), UrgoTech and neuroCare Group (Munich, Germany), and equipment support from Deymed, neuroConn and Magventure. Dr. Barterian has received royalties from Springer Nature. Dr. Dasgupta has operated an integrative medicine clinic in Asheville, NC. Dr. deBeus has received research funding from NIMH, has served on the Board of Directors for the International Society for Neurofeedback and Research, and has a clinic in NC where he performs neurofeedback among other clinical services. Dr. Hirshberg is the Owner and Director of the NeuroDevelopment Center, Inc., which provides neurofeedback and other psychological services. Dr. Hollway has received research funding from F. Hoffman-La Roche, Supernus Pharmaceuticals, Young Living, the National Institutes of Health (NIH), and Autism Speaks. She has served on the YAMO Pharmaceuticals advisory board and has consulted with MedAvante-ProPhase for Finch Therapeutics. Dr. Kerson is Founder, CEO, and Director of Applied Psychophysiology Education (APEd). Dr. McBurnett has received research funding from Otsuka American Pharmaceutical, Akili Interactive, and American Bri-Vision and has served on the speakers’ bureau for Ironshore. Dr. Monastra is the co-developer of the Thought Technology ADHD Assessment Suite and director of the FPI Attention Disorders Clinic. He has received equipment grants from Thought Technology and royalties from the Biofeedback Federation of Europe. He has received royalties for books and professional training videos on diagnosing and treating ADHD from the American Psychological Association. Dr. Roley-Roberts has received research funding from the American Psychological Foundation, the Foundation for Education and Research in Biofeedback and Related Sciences, the Foundation for Neurofeedback and Neuromodulation Research, NIMH, and NIH. Mr. Lightstone is founder and owner of EEG Software LLC. Drs. Black, Lofthouse, Lubar, Pan, Rice, Schrader, Williams, Mss. Bergman, Connor, Higgins, Buchan-Page, Rhodes, and Mr. Tan have reported no biomedical financial interests or potential conflicts of interest. |
Vol 60 - N° 7
P. 841-855 - juillet 2021 Retour au numéro
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