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Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers.

ABSTRACT: BACKGROUND:Tinnitus is a particularly common condition and can have debilitating psychological consequences for certain people. Although several interventions have been helpful in teaching individuals to better cope with tinnitus, no cure exists at present. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilising an alpha/delta training protocol, have shown promise. However, they were characterised by small sample sizes and a lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate whether an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing not only the tinnitus sound perception but also the psychological symptoms associated with the condition. METHODS:The study is designed as a three-armed randomised controlled trial. Participants are randomly assigned to a) an established neurofeedback protocol for tinnitus (alpha/delta training), b) an active control group (beta/theta training) or c) a diary control group. In the 4-week intervention period, participants in both neurofeedback groups undergo 10 sessions, whereas participants in the diary control group complete a bi-weekly diary. The primary outcomes are between group differences in tinnitus sound perception change, as measured with the Tinnitus Magnitude Index (TMI), and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), 4 weeks after the start of the intervention. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. DISCUSSION:This is the first randomised controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing tinnitus sound perception and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator and beta/theta neurofeedback training, in addition to controlling for placebo effects by the inclusion of a diary control group. This study aims to contribute to an understanding of the influences of both specific and non-specific effects in neurofeedback treatment for tinnitus. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03550430. Registered on 27 May 2018.

SUBMITTER: Jensen M

PROVIDER: S-EPMC7201543 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers.

Jensen Martin M Hüttenrauch Eva E Schmidt Jennifer J Andersson Gerhard G Chavanon Mira-Lynn ML Weise Cornelia C

Trials 20200505 1

<h4>Background</h4>Tinnitus is a particularly common condition and can have debilitating psychological consequences for certain people. Although several interventions have been helpful in teaching individuals to better cope with tinnitus, no cure exists at present. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilising an alpha/delta training protocol, have shown promise. However, they were characterised by small sample sizes and a lack of neurofeedback control ...[more]

PMID: 32370767

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Project description:First attempts have demonstrated that the application of alpha/delta neurofeedback in the treatment of chronic tinnitus leads to a reduction of symptoms at the group level. However, recent research also suggests that chronic tinnitus is a decidedly heterogeneous phenomenon, one that requires treatment of distinct subgroups or even on an individual level. Thus, the purpose of this study was to evaluate an individually adjusted alpha/delta neurofeedback protocol. Following previous studies, the delta band fixed between 3 and 4 Hz was chosen as the frequency for inhibition. However, unlike the previous studies, the frequency range for the rewarded alpha band was not fixed between 8 and 12 Hz but rather individually determined according to each patient's specific alpha peak frequency (IAF). Twenty-six chronic tinnitus patients participated in 15 weekly neurofeedback training sessions and extensive pre- and post-tests, as well as follow-up testing 3 and 6 months after training. The main outcome measures were tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and pre- and post-training resting-state EEG activity in trained frequency bands. In Results, the neurofeedback protocol led to a significant reduction of tinnitus-related distress and tinnitus loudness. While distress remained on a low level even 6 months after the completion of training, loudness returned to baseline levels in the follow-up period. In addition, resting-state EEG activity showed an increase in the trained alpha/delta ratio over the course of the training. This ratio increase was related to training-induced changes of tinnitus-related distress as measured with TQ, mainly due to increases in the alpha frequency range. In sum, this study confirms the alpha/delta neurofeedback as a suitable option for the treatment of chronic tinnitus and represents a first step towards the development of individual neurofeedback protocols. This clinical trial was registered online at ClinicalTrials.gov (NCT02383147) and kofam.ch (SNCTP000001313).

Project description:OBJECTIVE:To investigate the co-occurrence of tinnitus-related distress and pain experiences alongside psychological factors that may underlie their association. METHOD:Patients with chronic tinnitus (N = 1238) completed a questionnaire battery examining tinnitus-related distress and affective and sensory pain perceptions. A series of simple, parallel- and serial multiple mediator models examined indirect effects of psychological comorbidities as well as -process variables including depressivity, perceived stress and coping attitudes. Moderator and moderated mediation analyses examined differential relational patterns in patients with decompensated vs. compensated tinnitus. RESULTS:There were significant associations between tinnitus-related distress and pain perceptions. These were partially mediated by most specified variables. Psychological comorbidities appeared to influence tinnitus-pain associations through their impact on depressivity, perceived stress, and coping attitudes. Some specific differences in affective vs. sensory pain perception pathways emerged. Patients with decompensated tinnitus yielded significantly higher symptom burden across all measured indices. Tinnitus decompensation was associated with heightened associations between [1] tinnitus-related distress and pain perceptions, depressivity and negative coping attitudes; and [2] most psychological comorbidities and sensory, but not affective pain perception. Moderated mediation analyses revealed stronger indirect effects of depressivity and anxiety in mediating affective-, and anxiety in mediating sensory pain perception in patients with decompensated tinnitus. CONCLUSION:Psychological constructs mediate the co-occurrence of tinnitus- and pain-related symptoms across different levels of tinnitus-related distress. Psychological treatment approaches should conceptualize and address individualised interactions of common cognitive-emotional processes in addressing psychosomatic symptom clusters across syndromatic patients with varying distress levels.

Project description:The widespread understanding that chronic tinnitus is a heterogeneous phenomenon with various neural oscillatory profiles has spurred investigations into individualized approaches in its treatment. Neurofeedback, as a non-invasive tool for altering neural activity, has become increasingly popular in the personalized treatment of a wide range of neuropsychological disorders. Despite the success of neurofeedback on the group level, the variability in the treatment efficacy on the individual level is high, and evidence from recent studies shows that only a small number of people can effectively modulate the desired aspects of neural activity. To reveal who may be more suitable, and hence benefit most from neurofeedback treatment, we classified individuals into unobserved subgroups with similar oscillatory trajectories during the treatment and investigated how subgroup membership was predicted by a series of characteristics. Growth mixture modeling was used to identify distinct latent subgroups with similar oscillatory trajectories among 50 individuals suffering from chronic subjective tinnitus (38 male, 12 female, mean age = 47.1 ± 12.84) across 15 neurofeedback training sessions. Further, the impact of characteristics and how they predicted the affiliation in the identified subgroups was evaluated by including measures of demographics, tinnitus-specific (Tinnitus Handicap Inventory) and depression variables, as well as subjective quality of life subscales (World Health Organization-Quality of Life Questionnaire), and health-related quality of life subscales (Short Form-36) in a logistic regression analysis. A latent class model could be fitted to the longitudinal data with a high probability of correctly classifying distinct oscillatory patterns into 3 different groups: non-responder (80%), responder (16%), and decliner (4%). Further, our results show that the health-related wellbeing subscale of the Short Form-36 questionnaire was differentially associated with the groups. However, due to the small sample size in the Responder group, we are not able to provide sufficient evidence for a distinct responder profile. Nevertheless, the identification of oscillatory change-rate differences across distinct groups of individuals provides the groundwork from which to tease apart the complex and heterogeneous oscillatory processes underlying tinnitus and the attempts to modify these through neurofeedback. While more research is needed, our results and the analytical approach presented may bring clarity to contradictory past findings in the field of tinnitus research, and eventually influence clinical practice.

Dataset Information

Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers.

Publications

Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers.

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