Single-Blind Method

Research Papers

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Self-Directed Neurofeedback Treatment for Subjective Tinnitus Patients Evaluated by Multimodal Functional Imaging

Ma, Xiaoyan, Wang, Fangyuan, Zhang, Chi, Shen, Weidong, Yang, Shiming (2022) · Neural Plasticity

Neurofeedback (NFB) is a relatively novel approach to the treatment of tinnitus, and prior studies have demonstrated that the increases in alpha activity rather than reduced delta power seem to drive these NFB-related improvements in tinnitus symptoms. The present study was therefore designed to explore whether the implementation of an alpha training protocol with a portable neurofeedback apparatus would achieve improvements in tinnitus patient symptoms. In this study, 38 tinnitus patients underwent NFB training while 18 were enrolled in a control group. The study was single-blinded such that only participants were not aware of their group assignments. Those in the NFB group underwent 15 NFB training sessions over 5 weeks, in addition to pre- and posttraining tests including the Tinnitus Handicap Inventory (THI), Tinnitus Handicap Questionnaire (THQ), visual analog scales (VAS), electroencephalography (EEG), and functional magnetic resonance imaging (fMRI). Our result find that when the THI, THQ, and VAS scores of patients in the two groups were assessed after a 5-week training period, these scores were unchanged in control patients whereas they had significantly improved in the NFB group patients. EEG analyses revealed that the alpha band was increased in the occipital lobe following NFB treatment, while fMRI indicated an increase in regional homogeneity (ReHo) in the right frontal lobe of patients in the NFB group after treatment that was negatively correlated with THI and VAS scores. The results of this analysis indicate that alpha NFB training can be effectively used to reduce tinnitus-related distress and sound perception in patients.

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Clinical Effects of Immersive Multimodal BCI-VR Training after Bilateral Neuromodulation with rTMS on Upper Limb Motor Recovery after Stroke. A Study Protocol for a Randomized Controlled Trial

Sánchez-Cuesta, Francisco José, Arroyo-Ferrer, Aida, González-Zamorano, Yeray, Vourvopoulos, Athanasios, Badia, Sergi Bermúdez I., Figuereido, Patricia, Serrano, José Ignacio, Romero, Juan Pablo (2021) · Medicina (Kaunas, Lithuania)

Background and Objectives: The motor sequelae after a stroke are frequently persistent and cause a high degree of disability. Cortical ischemic or hemorrhagic strokes affecting the cortico-spinal pathways are known to cause a reduction of cortical excitability in the lesioned area not only for the local connectivity impairment but also due to a contralateral hemisphere inhibitory action. Non-invasive brain stimulation using high frequency repetitive magnetic transcranial stimulation (rTMS) over the lesioned hemisphere and contralateral cortical inhibition using low-frequency rTMS have been shown to increase the excitability of the lesioned hemisphere. Mental representation techniques, neurofeedback, and virtual reality have also been shown to increase cortical excitability and complement conventional rehabilitation. Materials and Methods: We aim to carry out a single-blind, randomized, controlled trial aiming to study the efficacy of immersive multimodal Brain-Computer Interfacing-Virtual Reality (BCI-VR) training after bilateral neuromodulation with rTMS on upper limb motor recovery after subacute stroke (>3 months) compared to neuromodulation combined with conventional motor imagery tasks. This study will include 42 subjects in a randomized controlled trial design. The main expected outcomes are changes in the Motricity Index of the Arm (MI), dynamometry of the upper limb, score according to Fugl-Meyer for upper limb (FMA-UE), and changes in the Stroke Impact Scale (SIS). The evaluation will be carried out before the intervention, after each intervention and 15 days after the last session. Conclusions: This trial will show the additive value of VR immersive motor imagery as an adjuvant therapy combined with a known effective neuromodulation approach opening new perspectives for clinical rehabilitation protocols.

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A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy

Ratcliff, Chelsea G., Prinsloo, Sarah, Chaoul, Alejandro, Zepeda, Stephanie G., Cannon, Rex, Spelman, Amy, Yang, Wei T., Cohen, Lorenzo (2019) · Journal of the American College of Radiology: JACR

PURPOSE: Stereotactic breast biopsy (SBB) is a common, anxiety-producing procedure. Nonpharmacologic methods to manage acute anxiety are needed. METHODS: In this single-blind trial, women were recruited before SBB and randomized in a 2:2:1 ratio to a single session of guided mindfulness-based meditation (GM; n = 30), focused breathing (FB; n = 30), or standard care (SC; n = 16). Anxiety and pain were assessed at baseline after a 10-min prebiopsy group-specific activity (GM, FB, or SC), every 4 min during SBB, and after biopsy. Electroencephalographic activity in the medial prefrontal cortex, insula, anterior cingulate cortex, and precuneus was collected throughout the study. RESULTS: Women in the GM group reported a steeper reduction in anxiety than women in the FB and SC groups (P < .001 for all, Cohen's d > 0.4 for all). There were no group differences in pain ratings during the biopsy. Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both). Women in the GM and FB groups experienced a nonsignificant decrease in delta activity in the precuneus during biopsy compared with those in the SC group (P < .40 for both, Cohen's d > 0.6 for both), which was associated with a steeper reduction in anxiety during the biopsy (r = 0.51, P < .01). CONCLUSIONS: Brief, guided meditation may provide effective anxiety relief during an acute medical procedure and affect neuronal activity in regions associated with attention, self-awareness, and emotion regulation.

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Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial

Marlats, Fabienne, Djabelkhir-Jemmi, Leila, Azabou, Eric, Boubaya, Marouane, Pouwels, Sjaak, Rigaud, Anne-Sophie (2019) · Trials

BACKGROUND: Older adults with Mild Cognitive Impairment (MCI) are at high risk of progressing to Alzheimer's disease (AD). Slowing down the effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback (NF) has shown promising results in improving working memory but has never been evaluated in people with MCI. We aim to examine whether NF training can decrease cognitive disorders, targeting memory, attention functions and brain electrical activity in elderly patients with MCI. METHODS: In this single-blind, randomized controlled trial (RCT) protocol, we will investigate the effects of two NF training protocols on cognitive performances and on brain electrical activity. Sixty MCI patients will be assigned either to an intervention program or to psycho-pedagogical care as a control condition. Participants in the intervention group will attend 30 sessions of sensorimotor/delta-ratio NF training or beta1/theta-ratio NF training. Neuropsychological assessment, questionnaires and electroencephalography (EEG) assessment parameters will be used as dependent variables in three periods: at baseline (T0), immediately after the last NF training session at 4 months (T1) and at 3-month follow-up (T2). The primary outcome will be the change in attention measured with the Trail Making Test B. Secondary outcome will be the changes in cognitive performance and in EEG activities. DISCUSSION: If the results of our study show improvement in cognitive performances of older adults with MCI, this non-invasive, low-cost technique may deserve better consideration as a therapeutic intervention to delay cognitive decline and dementia. Consequently, research in NF will need to review and develop the rigor of its application in gerontology. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03526692 . Registered on 16 May 2018.

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Neurofeedback training with a low-priced EEG device leads to faster alpha enhancement but shows no effect on cognitive performance: A single-blind, sham-feedback study

Naas, Adrian, Rodrigues, João, Knirsch, Jan-Philip, Sonderegger, Andreas (2019) · PloS One

INTRODUCTION: Findings of recent studies indicate that it is possible to enhance cognitive capacities of healthy individuals by means of individual upper alpha neurofeedback training (NFT). Although these results are promising, most of this research was conducted based on high-priced EEG systems developed for clinical and research purposes. This study addresses the question whether such effects can also be shown with an easy to use and comparably low-priced Emotiv Epoc EEG headset available for the average consumer. In addition, critical voices were raised regarding the control group designs of studies addressing the link between neurofeedback training and cognitive performance. Based on an extensive literature review revealing considerable methodological issues in an important part of the existing research, the present study addressed the question whether individual upper alpha neurofeedback has a positive effect on alpha amplitudes (i.e. increases alpha amplitudes) and short-term memory performance focussing on a methodologically sound, single-blinded, sham controlled design. METHOD: Participants (N = 33) took part in four test sessions over four consecutive days of either neurofeedback training (NFT group) or sham feedback (SF group). In the NFT group, five three-minute periods of visual neurofeedback training were administered each day whereas in the SF group (control group), the same amount of sham feedback was presented. Performance on eight digit-span tests as well as participants' affective states were assessed before and after each of the daily training sessions. RESULTS: NFT did not show an effect on individual upper alpha and cognitive performance. While performance increased in both groups over the course of time, this effect could not be explained by changes in individual upper alpha. Additional analyses however revealed that participants in the NFT group showed faster and larger increase in alpha compared to the SF group. Surprisingly, exploratory analyses showed a significant correlation between the initial alpha level and the alpha improvement during the course of the study. This finding suggests that participants with high initial alpha levels benefit more from alpha NFT interventions. In the discussion, the appearance of the alpha enhancement in the SF group and possible reasons for the absence of a connection between NFT and short-term memory are addressed.

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Targeting dynamic facial processing mechanisms in superior temporal sulcus using a novel fMRI neurofeedback target

Direito, Bruno, Lima, João, Simões, Marco, Sayal, Alexandre, Sousa, Teresa, Lührs, Michael, Ferreira, Carlos, Castelo-Branco, Miguel (2019) · Neuroscience

The superior temporal sulcus (STS) encompasses a complex set of regions involved in a wide range of cognitive functions. To understand its functional properties, neuromodulation approaches such brain stimulation or neurofeedback can be used. We investigated whether the posterior STS (pSTS), a core region in the face perception and imagery network, could be specifically identified based on the presence of dynamic facial expressions (and not just on simple motion or static face signals), and probed with neurofeedback. Recognition of facial expressions is critically impaired in autism spectrum disorder, making this region a relevant target for future clinical neurofeedback studies. We used a stringent localizer approach based on the contrast of dynamic facial expressions against static neutral faces plus moving dots. The target region had to be specifically responsive to dynamic facial expressions instead of mere motion and/or the presence of a static face. The localizer was successful in selecting this region across subjects. Neurofeedback was then performed, using this region as a target, with two novel feedback rules (mean or derivative-based, using visual or auditory interfaces). Our results provide evidence that a facial expression-selective cluster in pSTS can be identified and may represent a suitable target for neurofeedback approaches, aiming at social and emotional cognition. These findings highlight the presence of a highly selective region in STS encoding dynamic aspects of facial expressions. Future studies should elucidate its role as a mechanistic target for neurofeedback strategies in clinical disorders of social cognition such as autism.

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