Effects and Side Effects of Infraslow Network Neurofeedback (ISF-NF): a randomised double blind placebo controlled trial

Leong, Sook Ling; Vanneste, Sven; Lim, Jinwoong; Smith, Mark; Manning, Pamela T.; Ridder, Dirk De; Stoeckl-Drax, T.

doi:10.1016/j.ijpsycho.2018.07.402

Cited by 3 publications

(6 citation statements)

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“…To date, this is the rst study examining the effect of sLORETA eISF-NFB on IDs, thus no formal power calculations can be made. Our research group's previous sLORETA eISF-NFB feasibility study found signi cant differences in PROs and neurophysiological measures between the active and sham groups with an n=11 and n=10, respectively (194,195).…”

Section: Sample Size {14}mentioning

confidence: 78%

“…Advanced source-localization (i.e. standardized low resolution brain electromagnetic tomography; sLORETA) (193) combined with EEG-NFB targeting eISFs (sLORETA eISF-NFB) is novel introduction to the EEG-NFB eld that has been shown by our research group in a feasibility trial to improve, based upon patient reported outcomes (PROs), sleep and wellbeing with minimal side-effects in an obese female population (194,195). Additionally, it was shown to modulate ISFs within the targeted region-of-interest (ROI) (194).…”

Section: Background and Rationale {6a}mentioning

confidence: 99%

“…Participants may be withdrawn from the trial by the investigators, even without their request, in the event of serious adverse effects. As detailed in the PIS, a brief (4-item) interview used during our group's prior sLORETA eISF-NFB feasibility trial revealed that, although unusual or vivid dreams were experienced by some participants, there were no serious adverse effects (195).…”

Section: Adverse Event Reporting and Harms {22}mentioning

confidence: 99%

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The ISAD (Infraslow Neurofeedback for Anxiety and Depression) Study: A Protocol for a Trans-Diagnostic, Randomized, Double-Blind, Sham-Controlled, Dose-Response, Parallel-Group Trial

Perez

Paul

Adhia

et al. 2021

Preprint

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Background: The core intrinsic connectivity networks (ICNs), encompassing the default-mode network (DMN), salience network (SN) and central executive network (CEN), have been shown to be dysfunctional in individual’s with internalizing disorders (IDs; e.g. major depressive disorder, MDD; generalized anxiety disorder, GAD; social anxiety disorder, SOC). As such, source-localised electroencephalogram neurofeedback (EEG-NFB) therapy targeting key cortical nodes within these networks has the potential to reduce symptoms associated with IDs and restore normal core ICN function. We intend to conduct a transdiagnostic, randomized, double-blind, sham-controlled, dose-response, parallel-group trial of standardized low-resolution electromagnetic tomography electrophysiological infraslow (<0.1 Hz) fluctuation neurofeedback (sLORETA eISF-NFB) 3 times per week over 4 weeks in participants (n=60) with IDs. Our primary aim will be to assess the clinical efficacy of sLORETA eISF-NFB via relevant patient-reported outcomes (PROs). Methods: We will randomly assign participants with a current diagnosis of MDD, GAD, and/or SOC to one of four groups: 1) 12 sessions of posterior cingulate cortex (PCC) up-training (n=15), 2) 6 sessions of yoked-sham training followed by 6 sessions of PCC up-training (n=15), 3) 12 sessions of concurrent mid-cingulate (MCC) down-training and PCC up-training (n=15), or 4) 6 sessions of yoked-sham training followed by 6 sessions of concurrent MCC down-training and PCC up-training. Transdiagnostic PROs, as well as resting-state neuro-physiological measures (EEG; electrocardiography, ECG; electrodermal activity, EDA), will be collected from all subjects at baseline, mid-training, 1 week post-training, and 1 month post-training. We will further compare baseline PROs and neuro-physiological measures to age- and sex-matched non-ID (i.e. no ID diagnosis) controls. Discussion: This protocol will outline the rationale and research methodology for a clinical trial of sLORETA eISF-NFB targeting key nodes within the core ICNs in a population with IDs with the primary aim being to assess its specific (e.g. non-placebo induced) efficacy via PROs. Trial Registration: Our study was prospectively registered with the Australia New Zealand Clinical Trials Registry (ANZCTR; Trial Id: ACTRN12619001428156)

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Section: Sample Size {14}mentioning

confidence: 78%

Section: Background and Rationale {6a}mentioning

confidence: 99%

Section: Adverse Event Reporting and Harms {22}mentioning

confidence: 99%

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The ISAD (Infraslow Neurofeedback for Anxiety and Depression) Study: A Protocol for a Trans-Diagnostic, Randomized, Double-Blind, Sham-Controlled, Dose-Response, Parallel-Group Trial

Perez

Paul

Adhia

et al. 2021

Preprint

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“…Some clients experience enhanced nocturnal dreaming following neurofeedback sessions (Gruzelier, 2009;Johnson, 2011;Larsen & Verner, 2017;Leong et al, 2018a;Leong et al, 2018b). Reports of increased dreaming tend to be more common after a client's first few neurofeedback sessions, especially if the sessions are relatively long (30-40 minutes), although some clients may experience increased dreaming also through later stages of the training series and with shorter session durations.…”

Section: Increased Dreaming Following a Neurofeedback Sessionmentioning

confidence: 99%

Postsession Dreaming in Neurofeedback as an Indication of Nondeclarative Learning

Yonah¹

2020

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Clients may report increased dreaming following neurofeedback sessions. Increased dreaming may not be strictly a side effect of training but may rather be a result of the nondeclarative learning accomplished in training. Research has demonstrated the connection between dreaming and consolidation of memory in both animals and human subjects. Rapid eye movement (REM) deprivation studies have shown the importance of REM sleep to the retention of newly learned skills. Other studies have shown that learning may increase the proportion of REM sleep on subsequent nights. More specifically, REM dreaming may be related to the consolidation of procedural, nondeclarative memory, the type of learning that occurs also during neurofeedback training. When a client reports increased nocturnal dreaming following a neurofeedback session, this may serve as a valuable early indication that their brain is responding to this type of training.

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“…Advanced source-localization (i.e. standardized LORETA, sLORETA [ 62 ]) combined with ISF-NFB is a novel introduction to the field that has been shown by our research group in a feasibility trial on obese females to improve sleep and wellbeing with minimal side-effects [ 159 , 160 ].…”

Section: Introductionmentioning

confidence: 99%

Infraslow closed-loop brain training for anxiety and depression (ISAD): a protocol for a randomized, double-blind, sham-controlled pilot trial in adult females with internalizing disorders

Perez

Glue

Adhia

et al. 2022

Trials

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Background The core intrinsic connectivity networks (core-ICNs), encompassing the default-mode network (DMN), salience network (SN) and central executive network (CEN), have been shown to be dysfunctional in individuals with internalizing disorders (IDs, e.g. major depressive disorder, MDD; generalized anxiety disorder, GAD; social anxiety disorder, SOC). As such, source-localized, closed-loop brain training of electrophysiological signals, also known as standardized low-resolution electromagnetic tomography (sLORETA) neurofeedback (NFB), targeting key cortical nodes within these networks has the potential to reduce symptoms associated with IDs and restore normal core ICN function. We intend to conduct a randomized, double-blind (participant and assessor), sham-controlled, parallel-group (3-arm) trial of sLORETA infraslow (<0.1 Hz) fluctuation neurofeedback (sLORETA ISF-NFB) 3 times per week over 4 weeks in participants (n=60) with IDs. Our primary objectives will be to examine patient-reported outcomes (PROs) and neurophysiological measures to (1) compare the potential effects of sham ISF-NFB to either genuine 1-region ISF-NFB or genuine 2-region ISF-NFB, and (2) assess for potential associations between changes in PRO scores and modifications of electroencephalographic (EEG) activity/connectivity within/between the trained regions of interest (ROIs). As part of an exploratory analysis, we will investigate the effects of additional training sessions and the potential for the potentiation of the effects over time. Methods We will randomly assign participants who meet the criteria for MDD, GAD, and/or SOC per the MINI (Mini International Neuropsychiatric Interview for DSM-5) to one of three groups: (1) 12 sessions of posterior cingulate cortex (PCC) ISF-NFB up-training (n=15), (2) 12 sessions of concurrent PCC ISF up-training and dorsal anterior cingulate cortex (dACC) ISF-NFB down-training (n=15), or (3) 6 sessions of yoked-sham training followed by 6 sessions genuine ISF-NFB (n=30). Transdiagnostic PROs (Hospital Anxiety and Depression Scale, HADS; Inventory of Depression and Anxiety Symptoms – Second Version, IDAS-II; Multidimensional Emotional Disorder Inventory, MEDI; Intolerance of Uncertainty Scale – Short Form, IUS-12; Repetitive Thinking Questionnaire, RTQ-10) as well as resting-state neurophysiological measures (full-band EEG and ECG) will be collected from all subjects during two baseline sessions (approximately 1 week apart) then at post 6 sessions, post 12 sessions, and follow-up (1 month later). We will employ Bayesian methods in R and advanced source-localisation software (i.e. exact low-resolution brain electromagnetic tomography; eLORETA) in our analysis. Discussion This protocol will outline the rationale and research methodology for a clinical pilot trial of sLORETA ISF-NFB targeting key nodes within the core-ICNs in a female ID population with the primary aims being to assess its potential efficacy via transdiagnostic PROs and relevant neurophysiological measures. Trial registration Our study was prospectively registered with the Australia New Zealand Clinical Trials Registry (ANZCTR; Trial ID: ACTRN12619001428156). Registered on October 15, 2019.

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Effects and Side Effects of Infraslow Network Neurofeedback (ISF-NF): a randomised double blind placebo controlled trial

Cited by 3 publications

References 0 publications

The ISAD (Infraslow Neurofeedback for Anxiety and Depression) Study: A Protocol for a Trans-Diagnostic, Randomized, Double-Blind, Sham-Controlled, Dose-Response, Parallel-Group Trial

The ISAD (Infraslow Neurofeedback for Anxiety and Depression) Study: A Protocol for a Trans-Diagnostic, Randomized, Double-Blind, Sham-Controlled, Dose-Response, Parallel-Group Trial

Postsession Dreaming in Neurofeedback as an Indication of Nondeclarative Learning

Infraslow closed-loop brain training for anxiety and depression (ISAD): a protocol for a randomized, double-blind, sham-controlled pilot trial in adult females with internalizing disorders

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