Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up.
Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up.
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DOI:
10.1016/j.jaac.2020.07.906
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发表时间:
2021-07
影响因子:
13.3
通讯作者:
Neurofeedback Collaborative Group
中科院分区:
文献类型:
--
作者:
Neurofeedback Collaborative Group
To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit. In a 2-site double-blind randomized clinical trial, 144 children age 7–10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)≥4.5 were randomized 3:2 to deliberate TBR downtraining vs. a control of equal duration, intensity, and appearance. Two early dropouts left 142 for modified intent-to-treat analysis. The control utilized pre-recorded EEGs with participant’s artifacts superimposed. Treatment was programmed via internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists, 93.2% by NF expert monitor. Primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated. Blinding was excellent. While both groups showed significant improvement (p<0.001, 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=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up). Responders (CGI-I=1–2) were 61% of NF and 54% of Controls (p=.36). Adverse events were distributed proportionally between treatments. 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). 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. Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; https://clinicaltrials.gov/; NCT02251743.
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影响因子:
2.4
作者:
Monastra, VJ;Lubar, JF;Linden, M
通讯作者:
Linden, M
影响因子:
3
作者:
OMIZO, MM;MICHAEL, WB
通讯作者:
MICHAEL, WB
DOI:
10.1097/chi.0b013e31819c23d0
发表时间:
2009-05
影响因子:
13.3
作者:
Molina BSG;Hinshaw SP;Swanson JM;Arnold LE;Vitiello B;Jensen PS;Epstein JN;Hoza B;Hechtman L;Abikoff HB;Elliott GR;Greenhill LL;Newcorn JH;Wells KC;Wigal T;Gibbons RD;Hur K;Houck PR;MTA Cooperative Group
通讯作者:
MTA Cooperative Group
影响因子:
6.4
作者:
Geladé K;Bink M;Janssen TW;van Mourik R;Maras A;Oosterlaan J
通讯作者:
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影响因子:
3
作者:
Arnold LE;Lofthouse N;Hersch S;Pan X;Hurt E;Bates B;Kassouf K;Moone S;Grantier C
通讯作者:
Grantier C