Dataset Information

Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial.

ABSTRACT:

Objective

To examine delayed effects of theta-beta ratio (TBR) neurofeedback (NF) for attention-deficit/hyperactivity disorder (ADHD) 25 months after baseline, ∼21 months after end of treatment.

Method

Children aged 7 to 10 years with rigorously diagnosed ADHD had been randomized to 38 sessions of TBR NF (n = 84) or control treatment (n = 58) of identical appearance, intensity/frequency, and duration, differing only in that reinforcement for controls was based on a pre-recorded electroencephalogram (EEG) of another child. Child, parent, and all site staff were blinded until after 25-month assessments, with only one-fourth able to guess the control treatment correctly. Baseline assessments were repeated off medication after 25 months.

Results

Of the 142 participants, 120 had 25-month follow-up (84.5% retention). Only 12 participants (6 controls) had NF after the study treatment, greatly retaining the randomization. The primary outcome, parent-rated inattention, was not significantly different between treatments despite large pre-post effect sizes (NF recipients, d = 1.63; controls, d = 1.42). Most secondary measures showed the same pattern. Response rates (Clinical Global Impression-Improvement ≤2) were 58.6% of NF recipients and 66% of controls (not significant). Marginally more controls than NF recipients needed medication (57.1% vs 38.6%, p = .059); specifically, 7.1% of NF recipients and 4% of controls had reduced medication need, whereas 34.3% of NF recipients and 50% of controls needed more medication (p = 0.084).

Conclusion

Most of the large within-group improvement from the NF treatment package reported by unblinded studies and replicated in this blinded study reflects nonspecific effects, not specific effects of deliberate down-training of EEG theta-beta power ratio. At 25-month follow-up, it appears comparable to the evidence-based Multimodal Treatment Study of ADHD (MTA) treatments, suggesting a psychotherapeutic/behavioral effect.

Clinical trial registration information

Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; http://clinicaltrials.gov/; NCT02251743.

Diversity & inclusion statement

We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote sex and gender balance in our author group.

SUBMITTER: Neurofeedback Collaborative Group

PROVIDER: S-EPMC10065891 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial.

Journal of the American Academy of Child and Adolescent Psychiatry 20221212 4

<h4>Objective</h4>To examine delayed effects of theta-beta ratio (TBR) neurofeedback (NF) for attention-deficit/hyperactivity disorder (ADHD) 25 months after baseline, ∼21 months after end of treatment.<h4>Method</h4>Children aged 7 to 10 years with rigorously diagnosed ADHD had been randomized to 38 sessions of TBR NF (n = 84) or control treatment (n = 58) of identical appearance, intensity/frequency, and duration, differing only in that reinforcement for controls was based on a pre-recorded el ...[more]

PMID: 36521694

Similar Datasets

Project description:ObjectiveTo determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback [NF]) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.MethodIn 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.ResultsBlinding 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).ConclusionThis 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 informationDouble-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; https://clinicaltrials.gov/; NCT02251743.

Project description:BACKGROUND:Younger children in a school grade cohort may be more likely to receive a diagnosis of attention deficit-hyperactivity disorder (ADHD) than their older peers because of age-based variation in behavior that may be attributed to ADHD rather than to the younger age of the children. Most U.S. states have arbitrary age cutoffs for entry into public school. Therefore, within the same grade, children with birthdays close to the cutoff date can differ in age by nearly 1 year. METHODS:We used data from 2007 through 2015 from a large insurance database to compare the rate of ADHD diagnosis among children born in August with that among children born in September in states with and states without the requirement that children be 5 years old by September 1 for enrollment in kindergarten. ADHD diagnosis was determined on the basis of diagnosis codes from the International Classification of Diseases, 9th Revision. We also used prescription records to compare ADHD treatment between children born in August and children born in September in states with and states without the cutoff date of September 1. RESULTS:The study population included 407,846 children in all U.S. states who were born in the period from 2007 through 2009 and were followed through December 2015. The rate of claims-based ADHD diagnosis among children in states with a September 1 cutoff was 85.1 per 10,000 children (309 cases among 36,319 children; 95% confidence interval [CI], 75.6 to 94.2) among those born in August and 63.6 per 10,000 children (225 cases among 35,353 children; 95% CI, 55.4 to 71.9) among those born in September, an absolute difference of 21.5 per 10,000 children (95% CI, 8.8 to 34.0); the corresponding difference in states without the September 1 cutoff was 8.9 per 10,000 children (95% CI, -14.9 to 20.8). The rate of ADHD treatment was 52.9 per 10,000 children (192 of 36,319 children; 95% CI, 45.4 to 60.3) among those born in August and 40.4 per 10,000 children (143 of 35,353 children; 95% CI, 33.8 to 47.1) among those born in September, an absolute difference of 12.5 per 10,000 children (95% CI, 2.43 to 22.4). These differences were not observed for other month-to-month comparisons, nor were they observed in states with non-September cutoff dates for starting kindergarten. In addition, in states with a September 1 cutoff, no significant differences between August-born and September-born children were observed in rates of asthma, diabetes, or obesity. CONCLUSIONS:Rates of diagnosis and treatment of ADHD are higher among children born in August than among children born in September in states with a September 1 cutoff for kindergarten entry. (Funded by the National Institutes of Health.).

Project description:BackgroundAlthough the body of research concerning neurodevelopmental disorders is vast, there is a scarcity of longitudinal studies beyond late adolescence, and of studies taking co-existing disorders into account. The present study aimed to investigate outcome in adulthood for children with attention-deficit/hyperactivity disorder (ADHD) combined with developmental coordination disorder (DCD) diagnosed at 6.6 years of age.MethodsOut of a screening-based population cohort of 589 individuals, 62 (10 female) diagnosed with ADHD+DCD at mean age 6.6 years naïve to stimulant treatment were followed into adulthood through national registries. Results were compared to a screen- and assessment negative population matched group from the same cohort (PM group, n = 51) and a registry-matched (RM group, n = 410) group of the same county and age.ResultsAt 30 to 31 years of age, five deaths had occurred; one in the ADHD+DCD group and two each in the comparison groups. In time to event analyses of the composite outcome of any psychiatric disorder, psychotropic prescription, sick pension or criminal sentence, events occurred at a significantly higher rate in the ADHD+DCD group (p = 0.0032, vs PM group p = 0.0115, vs RM group p = 0.0054). The ADHD+DCD group had significantly higher rates of psychiatric diagnoses, prescriptions of psychoactive medications and occurrence of sick pension than both comparison groups. Further, the ADHD+DCD group had significantly lower educational attainment compared to both comparison groups, more years with unemployment, and overall higher welfare recipiency. Rates of pain diagnoses and analgesic prescriptions did not separate the groups.ConclusionADHD+DCD entailed a less favorable outcome in adulthood compared to a non-clinical comparison group and a registry-matched population. Neurodevelopmental disorder diagnosed upon school entry is of prognostic utility with respect to function in adulthood, and warrants early identification and management.

Dataset Information

Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial.

Objective

Method

Results

Conclusion

Clinical trial registration information

Diversity & inclusion statement

Publications

Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial.

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