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Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial.

ABSTRACT: BACKGROUND:Treatment for children with attention deficit/hyperactivity disorder (ADHD) today is predominantly pharmacological. While it is the most common treatment, it might not always be the most appropriate one. Moreover, long term effects remain unclear. Behavior therapy (BT) and non-pharmacological treatments such as neurofeedback (NF) are promising alternatives, though there are no routine outpatient care/effectiveness studies yet that have included children with medication or changes in medication. METHODS/DESIGN:This paper presents the protocol of a randomized controlled trial to compare the effectiveness of a Slow Cortical Potential (SCP) NF protocol with self-management (SM) in a high frequent outpatient care setting. Both groups (NF/SM) receive a total of 30 high frequent therapy sessions. Additionally, 6 sessions are reserved for comorbid problems. The primary outcome measure is the reduction of ADHD core symptoms according to parent and teacher ratings. PRELIMINARY RESULTS:Untill now 58 children were included in the study (48 males), with a mean age of 8.42 (1.34) years, and a mean IQ of 110 (13.37). Conners-3 parent and teacher ratings were used to estimate core symptom change. Since the study is still ongoing, and children are in different study stages, pre-post and follow-up results are not yet available for all children included. Preliminary results suggest overall good pre-post effects, though. For parent and teacher ratings an ANOVA with repeated measures yielded overall satisfying pre-post effects (? (2) 0.175-0.513). Differences between groups (NF vs. SM) could not yet be established (p = 0.81). DISCUSSION:This is the first randomized controlled trial to test the effectiveness of a NF protocol in a high frequent outpatient care setting that does not exclude children on or with changes in medication. First preliminary results show positive effects. The rationale for the trial, the design, and the strengths and limitations of the study are discussed. TRIAL REGISTRATION:This trial is registered in www.clinicaltrials.gov as NCT01879644.

SUBMITTER: Christiansen H

PROVIDER: S-EPMC4244863 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial.

Christiansen Hanna H Reh Verena V Schmidt Martin H MH Rief Winfried W

Frontiers in human neuroscience 20141126

<h4>Background</h4>Treatment for children with attention deficit/hyperactivity disorder (ADHD) today is predominantly pharmacological. While it is the most common treatment, it might not always be the most appropriate one. Moreover, long term effects remain unclear. Behavior therapy (BT) and non-pharmacological treatments such as neurofeedback (NF) are promising alternatives, though there are no routine outpatient care/effectiveness studies yet that have included children with medication or chan ...[more]

PMID: 25505396

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Project description:METHOD:We collected 130 short semi-structured interviews following treatment sessions from 30 participants with ADHD receiving NF using slow cortical potential training (SCP). The interviews were transcribed verbatim and analyzed using thematic analysis. Themes where evaluated for changes over-time and between participants with high/low treatment compliance. Interviews from 14 participants who had undergone at least five completed interviews were examined in more depths, aiming to establish typical strategy/training profiles. RESULTS:We identified 16 strategies covering four domains: cognitive, physiological, emotional and unspecified. Typical of most strategies were that they served as a vehicle to regulate mental arousal. Overall, no clear patterns of changes over time were found. Highly compliant participants reported to use the strategies from the emotional domain and the strategy focus more frequently than neutral compliant participants did, while neutral compliant participants reported the use of the strategies muscular activity and passivity more often than participants did with high compliance. Across participants, three strategy profiles were derived, those who handled the task by manipulating their state of mind in relation to the NF task, those who were mainly manifest and concrete towards the task, and those who were mostly unaware of what they were doing. These profiles differed in self-regulatory performance, and only participants showing the state of mind profile experienced a decrease of ADHD symptoms accompanied by objectively measured improvements in self-regulation. In addition, compliance affected both how and what strategies were used. CONCLUSION/DISCUSSION:A heterogeneous array of cognitive and other strategies is used at varying levels of training compliance by participants with ADHD during SCP that could be condensed to three prototypical profiles. Future research should take compliance and strategy/training profiles into account when evaluating NF. The latter may help to clarify which and how brain activity regulating mechanisms drive training, individual response to NF, and how they are influenced by motivational factors. Our findings might also help to facilitate more effective instructions in how to approach SCP in clinical practice.

Project description:PurposeTo present a new outcomes-based registry to collect data on outpatient endovascular interventions, a relatively new site of service without adequate historical data to assess best clinical practices. Quality data collection with subsequent outcomes analysis, benchmarking, and direct feedback is necessary to achieve optimal care.Materials and methodsThe Outpatient Endovascular and Interventional Society (OEIS) established the OEIS National Registry in 2017 to collect data on safety, efficacy, and quality of care for outpatient endovascular interventions. Since then, it has grown to include a peripheral artery disease (PAD) module with plans to expand to include cardiac, venous, dialysis access, and other procedures in future modules. As a Qualified Clinical Data Registry approved by the Centers for Medicare and Medicaid Services, this application also supports new quality measure development under the Quality Payment Program. All physicians operating in an office-based laboratory or ambulatory surgery center can use the Registry to analyze de-identified data and benchmark performance against national averages. Major adverse events were defined as death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery.ResultsSince Registry inception in 2017, 251 participating physicians from 64 centers located in 18 states have participated. The current database includes 18,134 peripheral endovascular interventions performed in 12,403 PAD patients (mean age 72.3±10.2 years; 60.1% men) between January 2017 and January 2020. Cases were performed primarily in an office-based laboratory (85.1%) or ambulatory surgery center setting (10.4%). Most frequently observed procedure indications from 16,086 preprocedure form submissions included claudication (59%), minor tissue loss (16%), rest pain (9%), acute limb ischemia (5%), and maintenance of patency (3%). Planned diagnostic procedures made up 12.2% of cases entered, with the remainder indicated as interventional procedures (87.6%). The hospital transfer rate was 0.62%, with 88 urgent/emergent transfers and 24 elective transfers. The overall complication rate for the Registry was 1.87% (n=338), and the rate of major adverse events was 0.51% (n=92). Thirty-day mortality was 0.03% (n=6).ConclusionThis report describes the current structure, methodology, and preliminary results of OEIS National Registry, an outcomes-based registry designed to collect quality performance data with subsequent outcome analysis, benchmarking, and direct feedback to aid clinicians in providing optimal care.

Project description:Autism spectrum disorder is (ASD) characterized by a persisting triad of impairments of social interaction, language as well as inflexible, stereotyped and ritualistic behaviors. Increasingly, scientific evidence suggests a neurobiological basis of these emotional, social and cognitive deficits in individuals with ASD. The aim of this randomized controlled brain self-regulation intervention study was to investigate whether the core symptomatology of ASD could be reduced via an electroencephalography (EEG) based brain self-regulation training of Slow Cortical Potentials (SCP). 41 male adolescents with ASD were recruited and allocated to a) an experimental group undergoing 24 sessions of EEG-based brain training (n1 = 21), or to b) an active control group undergoing conventional treatment (n2 = 20), that is, clinical counseling during a 3-months intervention period. We employed real-time neurofeedback training recorded from a fronto-central electrode intended to enable participants to volitionally regulate their brain activity. Core autistic symptomatology was measured at six time points during the intervention and analyzed with Bayesian multilevel approach to characterize changes in core symptomatology. Additional Bayesian models were formulated to describe the neural dynamics of the training process as indexed by SCP (time-domain) and power density (PSD, frequency-domain) measures. The analysis revealed a substantial improvement in the core symptomatology of ASD in the experimental group (reduction of 21.38 points on the Social Responsiveness Scale, SD = 5.29), which was slightly superior to that observed in the control group (evidence Ratio = 5.79). Changes in SCP manifested themselves as different trajectories depending on the different feedback conditions and tasks. Further, the model of PSD revealed a continuous decrease in delta power, parallel to an increase in alpha power. Most notably, a non-linear (quadratic) model turned out to be better at predicting the data than a linear model across all analyses. Taken together, our analyses suggest that behavioral and neural processes of change related to neurofeedback training are complex and non-linear. Moreover, they have implications for the design of future trials and training protocols.

Project description:Neurofeedback (NF) aims to alter neural activity by enhancing self-regulation skills. Over the past decade NF has received considerable attention as a potential intervention option for many somatic and mental conditions and ADHD in particular. However, placebo-controlled trials have demonstrated insufficient superiority of NF compared to treatment as usual and sham conditions. It has been argued that the reason for limited NF effects may be attributable to participants' challenges to self-regulate the targeted neural activity. Still, there is support of NF efficacy when only considering so-called "standard protocols," such as Slow Cortical Potential NF training (SCP-NF). This PROSPERO registered systematic review following PRISMA criteria searched literature databases for studies applying SCP-NF protocols. Our review focus concerned the operationalization of self-regulatory success, and protocol-details that could influence the evaluation of self-regulation. Such details included; electrode placement, number of trials, length per trial, proportions of training modalities, handling of artifacts and skill-transfer into daily-life. We identified a total of 63 eligible reports published in the year 2000 or later. SCP-NF protocol-details varied considerably on most variables, except for electrode placement. However, due to the increased availability of commercial systems, there was a trend to more uniform protocol-details. Although, token-systems are popular in SCP-NF for ADHD, only half reported a performance-based component. Also, transfer exercises have become a staple part of SCP-NF. Furthermore, multiple operationalizations of regulatory success were identified, limiting comparability between studies, and perhaps usefulness of so-called transfer-exercises, which purpose is to facilitate the transfer of the self-regulatory skills into every-day life. While studies utilizing SCP as Brain-Computer-Interface mainly focused on the acquisition of successful self-regulation, clinically oriented studies often neglected this. Congruently, rates of successful regulators in clinical studies were mostly low (<50%). The relation between SCP self-regulation and behavior, and how symptoms in different disorders are affected, is complex and not fully understood. Future studies need to report self-regulation based on standardized measures, in order to facilitate both comparability and understanding of the effects on symptoms. When applied as treatment, future SCP-NF studies also need to put greater emphasis on the acquisition of self-regulation (before evaluating symptom outcomes).Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021260087, Identifier: CRD42021260087.

Project description:IntroductionNeurofeedback based on functional magnetic resonance imaging allows for learning voluntary control over one's own brain activity, aiming to enhance cognition and clinical symptoms. We previously reported improved sustained attention temporarily by training healthy participants to up-regulate the differential activity of the sustained attention network minus the default mode network (DMN). However, the long-term brain and behavioral effects of this training have not yet been studied. In general, despite their relevance, long-term learning effects of neurofeedback training remain under-explored.MethodsHere, we complement our previously reported results by evaluating the neurofeedback training effects on functional networks involved in sustained attention and by assessing behavioral and brain measures before, after, and 2 months after training. The behavioral measures include task as well as questionnaire scores, and the brain measures include activity and connectivity during self-regulation runs without feedback (i.e., transfer runs) and during resting-state runs from 15 healthy individuals.ResultsNeurally, we found that participants maintained their ability to control the differential activity during follow-up sessions. Further, exploratory analyses showed that the training increased the functional connectivity between the DMN and the occipital gyrus, which was maintained during follow-up transfer runs but not during follow-up resting-state runs. Behaviorally, we found that enhanced sustained attention right after training returned to baseline level during follow-up.ConclusionThe discrepancy between lasting regulation-related brain changes but transient behavioral and resting-state effects raises the question of how neural changes induced by neurofeedback training translate to potential behavioral improvements. Since neurofeedback directly targets brain measures to indirectly improve behavior in the long term, a better understanding of the brain-behavior associations during and after neurofeedback training is needed to develop its full potential as a promising scientific and clinical tool.

Project description:To develop a real-time neurofeedback system from the anterior prefrontal cortex (aPFC) using functional near-infrared spectroscopy (fNIRS) for motor rehabilitation, we investigated the effects of motor imagery training with neurofeedback from the aPFC on hand dexterity and cerebral hemodynamic activity during a motor rehabilitation task. Thirty-one right-handed healthy subjects participated in this study. They received motor imagery training six times for 2 weeks under fNIRS neurofeedback from the aPFC, in which they were instructed to increase aPFC activity. The real group subjects (n = 16) were shown real fNIRS neurofeedback signals from the aPFC, whereas the sham group subjects (n = 15) were shown irrelevant randomized signals during neurofeedback training. Before and after the training, hand dexterity was assessed by a motor rehabilitation task, during which cerebral hemodynamic activity was also measured. The results indicated that aPFC activity was increased during the training, and performance improvement rates in the rehabilitation task after the training was increased in the real group when compared with the sham group. Improvement rates of mean aPFC activity across the training were positively correlated with performance improvement rates in the motor rehabilitation task. During the motor rehabilitation task after the training, the hemodynamic activity in the left somatosensory motor-related areas [premotor area (PM), primary motor area (M1), and primary somatosensory area (S1)] was increased in the real group, whereas the hemodynamic activity was increased in the supplementary motor area in the sham group. This hemodynamic activity increases in the somatosensory motor-related areas after the training correlated with aPFC activity during the last 2 days of motor imagery training. Furthermore, improvement rates of M1 hemodynamic activity after the training was positively correlated with performance improvement rates in the motor rehabilitation task. The results suggest that the aPFC might shape activity in the somatosensory motor-related areas to improve hand dexterity. These findings further suggest that the motor imagery training using neurofeedback signals from the aPFC might be useful to patients with motor disability.

Project description:Background: Neurofeedback (NF) in children with attention-deficit/hyperactivity disorder (ADHD) has been investigated in a series of studies over the last years. Previous studies did not unanimously support NF as a treatment in ADHD. Most studies did not control for unspecific treatment effects and did not demonstrate that self-regulation took place. The present study examined the efficacy of NF in comparison to electromyographic (EMG) feedback to control for unspecific effects of the treatment, and assessed self-regulation of slow cortical potentials (SCPs). Methods: A total of 150 children aged 7-9 years diagnosed with ADHD (82% male; 43% medicated) were randomized to 25 sessions of feedback of SCPs (NF) or feedback of coordination of the supraspinatus muscles (EMG). The primary endpoint was the change in parents' ratings of ADHD core symptoms 4 weeks after the end of treatment compared to pre-tests. Results: Children in both groups showed reduced ADHD-core symptoms (NF 0.3, 95% CI -0.42 to -0.18; EMG 0.13, 95% CI -0.26 to -0.01). NF showed a significant superiority over EMG (treatment difference 0.17, 95% CI 0.02-0.3, p = 0.02). This yielded an effect size (ES) of d = 0.57 without and 0.40 with baseline observation carried forward (BOCF). The sensitivity analysis confirmed the primary result. Successful self-regulation of brain activity was observed only in NF. As a secondary result teachers reported no superior improvement from NF compared to EMG, but within-group analysis revealed effects of NF on the global ADHD score, inattention, and impulsivity. In contrast, EMG feedback did not result in changes despite more pronounced self-regulation learning. Conclusions: Based on the primary parent-rated outcome NF proved to be superior to a semi-active EMG feedback treatment. The study supports the feasibility and efficacy of NF in a large sample of children with ADHD, based on both specific and unspecific effects. Trial Register: Current controlled trials ISRCTN76187185, registered 5 February 2009.

Project description:Neurofeedback is widely applied as non-pharmacological intervention aimed at reducing symptoms of ADHD, even though efficacy has not been unequivocally established. Neuronal changes during the neurofeedback intervention that resemble learning can provide crucial evidence for the feasibility and specificity of this intervention. A total of 38 children (aged between 7 and 13 years) with a DSM-IV-TR diagnosis of ADHD, completed on average 29 sessions of theta (4-8 Hz)/beta (13-20 Hz) neurofeedback training. Dependent variables included training-related measures as well as theta and beta power during baseline and training runs for each session. Learning effects were analyzed both within and between sessions. To further specify findings, individual learning curves were explored and correlated with behavioral changes in ADHD symptoms. Over the course of the training, there was a linear increase in participants' mean training level, highest obtained training level and the number of earned credits (range b = 0.059, -0.750, p < 0.001). Theta remained unchanged over the course of the training, while beta activity increased linearly within training sessions (b = 0.004, 95% CI = [0.0013-0.0067], p = 0.005) and over the course of the intervention (b = 0.0052, 95% CI = [0.0039-0.0065], p < 0.001). In contrast to the group analyses, significant individual learning curves were found for both theta and beta over the course of the intervention in 39 and 53%, respectively. Individual learning curves were not significantly correlated with behavioral changes. This study shows that children with ADHD can gain control over EEG states during neurofeedback, although a lack of behavioral correlates may indicate insufficient transfer to daily functioning, or to confounding reinforcement of electromyographic activity.Clinical trials registrationThis trial is registered at the US National Institutes of Health (ClinicalTrials.gov, ref. no: NCT01363544); https://clinicaltrials.gov/show/NCT01363544 .

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Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial.

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Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial.

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