The out-of-pocket expenses of people with tinnitus in Europe.

BACKGROUND: Despite the high frequency of tinnitus and its impact on wellbeing, little is known about its economic burden and no data to our knowledge are available on out-of-pocket (OOP) expenses. METHODS: In 2022 a survey was conducted on OOP costs of tinnitus. We enrolled 679 participants with slight, moderate and severe tinnitus in Italy, United Kingdom, Netherlands, Germany and Spain. We estimated annual OOP expenses for tinnitus-related healthcare visits, treatments, medications and alternative medicine practices. Prevalence of tinnitus in the general population, obtained from a representative survey we conducted in Europe in 2017-2018, was used to generalise costs for people with any tinnitus at the national level. RESULTS: OOP expenses were 368€ (95% confidence intervals (CI), 78€-690€), 728€ (95% CI, 316€-1,288€), and 1,492€ (95% CI, 760€-2,688€) for slight, moderate, and severe tinnitus, respectively, with annual expenditure of 565€ for people with any tinnitus: 209€ for healthcare visits, 93€ for treatments, 16€ for drugs, 64€ for hearing supporting systems and 183€ for acupuncture, homeopathy and osteopathy. Individuals with slight, moderate, and severe tinnitus expressed a willingness to invest 1.6, 4.3, and 7.0 times their monthly income, respectively, to achieve complete relief from tinnitus. CONCLUSIONS: This study offers for the first time insights into the OOP expenses incurred by individuals with tinnitus. OOP expenses exhibited substantial variations based on severity status, accounting for more than 17 thousand million€ in the countries considered. In terms of financial burden, these findings align tinnitus to the recognised leading disabilities, including back pain and migraine.

Monitoring Changes in TMS-Evoked EEG and EMG Activity During 1†Hz rTMS of the Healthy Motor Cortex.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique capable of inducing neuroplasticity as measured by changes in peripheral muscle electromyography (EMG) or electroencephalography (EEG) from pre-to-post stimulation. However, temporal courses of neuromodulation during ongoing rTMS are unclear. Monitoring cortical dynamics via TMS-evoked responses using EMG (motor-evoked potentials; MEPs) and EEG (transcranial-evoked potentials; TEPs) during rTMS might provide further essential insights into its mode of action - temporal course of potential modulations. The objective of this study was to first evaluate the validity of online rTMS-EEG and rTMS-EMG analyses, and second to scrutinize the temporal changes of TEPs and MEPs during rTMS. As rTMS is subject to high inter-individual effect variability, we aimed for single-subject analyses of EEG changes during rTMS. Ten healthy human participants were stimulated with 1,000 pulses of 1 Hz rTMS over the motor cortex, while EEG and EMG were recorded continuously. Validity of MEPs and TEPs measured during rTMS was assessed in sensor and source space. Electrophysiological changes during rTMS were evaluated with model fitting approaches on a group- and single-subject level. TEPs and MEPs appearance during rTMS was consistent with past findings of single pulse experiments. Heterogeneous temporal progressions, fluctuations or saturation effects of brain activity were observed during rTMS depending on the TEP component. Overall, global brain activity increased over the course of stimulation. Single-subject analysis revealed inter-individual temporal courses of global brain activity. The present findings are in favor of dose-response considerations and attempts in personalization of rTMS protocols.

Variability of pulse width in transcranial magnetic stimulation.

Objective.There is a high variability in the physiological effects of transcranial magnetic brain stimulation, resulting in limited generalizability of measurements. The cause of the variability is assumed to be primarily based on differences in brain function and structure of the stimulated individuals, while the variability of the physical properties of the magnetic stimulus has so far been largely neglected. Thus, this study is dedicated to the systematic investigation of variability in the pulse width of different TMS pulse sources at different stimulation intensities.Approach.The pulse widths of seven MagVenture® pulse sources were measured at the output of 10%-100% stimulation intensity in 10% increments via Near Field Probe and oscilloscope. The same C-B60 coil was used to deliver biphasic pulses. Pulse widths were compared between pulse sources and stimulation intensities.Main results.The mean sample pulse width was 288.11 ± 0.37µs, which deviates from the value of 280µs specified by the manufacturer. The pulse sources and stimulation intensities differ in their average pulse width (p's< .001). However, the coefficient of variation within the groups (pulse source; stimulation intensity) were moderately low (CV = 0.13%-0.67%).Significance.The technical parameter of pulse width shows deviations from the proposed manufacturer value. According to our data, within a pulse source of the same manufacturer, the pulse width variability is minimal, but varies between pulse sources of the same and other pulse source models. Whether the observed variability in pulse width has potential physiological relevance was tested in a pilot experiment on a single healthy subject, showing no significant difference in motor evoked potential amplitude and significant difference in latencies. Future research should systematically investigate the physiological effects of different pulse lengths. Furthermore, potential hardware ageing effects and pulse amplitude should be investigated.

Treating depression at home with transcranial direct current stimulation: a feasibility study.

Introduction: Treating major depressive disorder (MDD) with transcranial direct current stimulation (tDCS) devices at home has various logistic advantages compared to tDCS treatment in the clinic. However, preliminary (controlled) studies showed side effects such as skin lesions and difficulties in the implementation of home-based tDCS. Thus, more data are needed regarding the feasibility and possible disadvantages of home-based tDCS. Methods: Ten outpatients (23-69 years) with an acute depressive episode were included for this one-arm feasibility study testing home-based tDCS. All patients self-administered prefrontal tDCS (2 mA, 20 min, anodal left, cathodal right) at home on 30 consecutive working days supported by video consultations. Correct implementation of the home-based treatment was analyzed with tDCS recordings. Feasibility was examined by treatment compliance. For additional analyses of effectiveness, three depression scores were used: Hamilton depression rating scale (HDRS-21), Major Depression Inventory (MDI), and the subscale depression of the Depression-Anxiety-Stress Scale (DASS). Furthermore, usability was measured with the user experience questionnaire (UEQ). Tolerability was analyzed by the number of reported adverse events (AEs). Results: Eight patients did not stick to the protocol. AEs were minimal. Four patients responded to the home treatment according to the MDI. Usability was judged positive by the patients. Conclusions: Regular video consultations or other safety concepts are recommended regardless of the number of video sessions actually conducted. Home-based tDCS seems to be safe and handy in our feasibility study, warranting further investigation.

Tinnitus: A Dimensionally Segregated, yet Perceptually Integrated Heterogeneous Disorder.

OBJECTIVES: Tinnitus subtypes are proposed to lie on a continuum of different symptom dimensions rather than be categorical. However, there is no comprehensive empirical data showing this complex relationship between different tinnitus symptoms. The objective of this study is to provide empirical evidence for the dimensional nature of tinnitus and how different auditory and non-auditory symptoms interact with each other through complex interactions. We do this using graph theory, a mathematical tool that empirically maps this complex interaction. This way, graph theory can be utilised to highlight a new and possibly important outlook on how we can understand the heterogeneous nature of tinnitus. DESIGN: In the current study, we use the screening databases of the Treatment Evaluation of Neuromodulation for Tinnitus-Stage A1 (TENT-A1) and A2 (TENT-A2) randomised trials to delineate the dimensional relationship between different clinical measures of tinnitus as a secondary data analysis. We first calculate the empirical relationship by computing the partial correlation. Following this, we use different measures of centrality to describe the contribution of different clinical measures to the overall network. We also calculate the stability of the network and compare the similarity and differences between TENT-A1 and TENT-A2. RESULTS: Components of the auditory subnetwork (loudness discomfort level, sound sensitivity, average hearing loss and high frequency hearing loss) are highly inter-connected in both networks with sound sensitivity and loudness discomfort level being highly influential with high measures of centrality. Furthermore, the relationship between the densely connected auditory subnetwork with tinnitus-related distress seems to vary at different levels of distress, hearing loss, duration and age of the participants. CONCLUSION: Our findings provide first-time evidence for tinnitus varying in a dimensional fashion illustrating the heterogeneity of this phantom percept and its ability to be perceptually integrated, yet behaviourally segregated on different symptomatic dimensions.

Single sessions of transcranial direct current stimulation and transcranial random noise stimulation exert no effect on sleepiness in patients with narcolepsy and idiopathic hypersomnia.

Background: Hypersomnia poses major challenges to treatment providers given the limitations of available treatment options. In this context, the application of non-invasive brain stimulation techniques such as transcranial electrical stimulation (tES) may open up new avenues to effective treatment. Preliminary evidence suggests both acute and longer-lasting positive effects of transcranial direct current stimulation (tDCS) on vigilance and sleepiness in hypersomniac patients. Based on these findings, the present study sought to investigate short-term effects of single sessions of tDCS and transcranial random noise stimulation (tRNS) on sleepiness in persons suffering from hypersomnia. Methods: A sample of 29 patients suffering from narcolepsy or idiopathic hypersomnia (IH) was recruited from the Regensburg Sleep Disorder Center and underwent single sessions of tES (anodal tDCS, tRNS, sham) over the left and right dorsolateral prefrontal cortex on three consecutive days in a double-blind, sham-controlled, pseudorandomized crossover trial. The primary study endpoint was the mean reaction time measured by the Psychomotor Vigilance Task (PVT) before and directly after the daily tES sessions. Secondary endpoints were additional PVT outcome metrics as well as subjective outcome parameters (e.g., Karolinska Sleepiness Scale; KSS). Results: There were no significant treatment effects neither on objective (i.e., PVT) nor on subjective indicators of sleepiness. Conclusion: We could not demonstrate any clinically relevant effects of single sessions of tDCS or tRNS on objective or subjective measures of sleepiness in patients with hypersomnia. However, we cannot exclude that repeated sessions of tES may affect vigilance or sleepiness in hypersomniac patients.

Deep brain stimulation for treatment resistant obsessive compulsive disorder; an observational study with ten patients under real-life conditions.

Introduction: Obsessive-compulsive disorder (OCD) affects 2-3% of the global population, causing distress in many functioning levels. Standard treatments only lead to a partial recovery, and about 10% of the patients remain treatment-resistant. Deep brain stimulation offers a treatment option for severe, therapy-refractory OCD, with a reported response of about 60%. We report a comprehensive clinical, demographic, and treatment data for patients who were treated with DBS in our institution. Methods: We offered DBS to patients with severe chronic treatment resistant OCD. Severity was defined as marked impairment in functioning and treatment resistance was defined as non-response to adequate trials of medications and psychotherapy. Between 2020 and 2022, 11 patients were implanted bilaterally in the bed nucleus of stria terminalis (BNST). Patients were evaluated with YBOCS, MADRS, GAF, CGI, and WHOQOL-BREF. We performed the ratings at baseline (before surgery), after implantation before the start of the stimulation, after reaching satisfactory stimulation parameters, and at follow-up visits 3, 6, 9, and 12 months after optimized stimulation. Results: One patient has retracted his consent to publish the results of his treatment, thus we are reporting the results of 10 patients (5 males, 5 females, mean age: 37 years). Out of our 10 patients, 6 have shown a clear response indicated by a YBOCS-reduction between 42 and 100 percent at last follow-up. One further patient experienced a subjectively dramatic effect on OCD symptoms, but opted afterwards to stop the stimulation. The other 3 patients showed a slight, non-significant improvement of YBOCS between 8.8 and 21.9%. The overall mean YBOCS decreased from 28.3 at baseline to 13.3 (53% reduction) at the last follow-up. The improvement of the OCD symptoms was also accompanied by an improvement of depressive symptoms, global functioning, and quality of life. Conclusion: Our results suggest that BNST-DBS can be effective for treatment-resistant OCD patients, as indicated by a reduction in symptoms and an overall improvement in functioning. Despite the need for additional research to define the patients' selection criteria, the most appropriate anatomical target, and the most effective stimulation parameters, improved patient access for this therapy should be established.

Tinnitus and treatment-resistant depression.

Tinnitus, a frequent disorder, is the conscious perception of a sound in the absence of a corresponding external acoustic sound source in the sense of a phantom sound. Although the majority of people who perceive a tinnitus sound can cope with it and are only minimaly impaired in their quality of lfe, 2-3% of the population perceive tinnitus as a major problem. Recently it has been proposed that the two groups should be differentiated by distict terms: "Tinnitus" describes the auditory or sensory component, whereas "Tinnitus Disorder" reflects the auditory component and the associated suffering. There is overwhelming evidence that a high tinnitus burden is associated with the increased occurrence of comorbidities, including depression. Since no causal therapeutic options are available for patients with tinnitus at the present time, the identification and adequate treatment of relevant comorbidities is of great importance for the reduction of tinnitus distress. This chapter deals with the relationship between tinnitus and depression. The neuronal mechanisms underlying tinnitus will first be discussed. There will also be an overview about depression and treatment resistant depression (TRD). A comprehensive review about the state-of-the-art evidences of the relationship between tinnitus and TRD will then be provided.

On the reliability of motor evoked potentials in hand muscles of healthy adults: a systematic review.

Aims: Motor evoked potentials (MEP) elicited by transcranial magnetic stimulation (TMS) over the primary motor cortex are used as a neurophysiological marker of cortical excitability in clinical and scientific practice. Though, the reliability of this outcome parameter has not been clarified. Using a systematic approach, this work reviews and critically appraises studies on the reliability of MEP outcome parameters derived from hand muscles of healthy subjects and gives a proposal for most reliable TMS practice. Methods: A systematic literature research was performed in PubMed, according to the PRISMA guidelines. Articles published up to March 2023 that were written in English, conducted repeated measurements from hand muscles of healthy subjects and reliability analysis were included. The risk of publication bias was determined. Two authors conducted the literature search and rated the articles in terms of eligibility and methodological criteria with standardized instruments. Frequencies of the checklist criteria were calculated and inter-rater reliability of the rating procedure was determined. Reliability and stimulation parameters were extracted and summarized in a structured way to conclude best-practice recommendation for reliable measurements. Results: A total of 28 articles were included in the systematic review. Critical appraisal of the studies revealed methodological heterogeneity and partly contradictory results regarding the reliability of outcome parameters. Inter-rater reliability of the rating procedure was almost perfect nor was there indication of publication bias. Identified studies were grouped based on the parameter investigated: number of applied stimuli, stimulation intensity, reliability of input-output curve parameters, target muscle or hemisphere, inter-trial interval, coil type or navigation and waveform. Conclusion: The methodology of studies on TMS is still subject to heterogeneity, which could contribute to the partly contradictory results. According to the current knowledge, reliability of the outcome parameters can be increased by adjusting the experimental setup. Reliability of single pulse MEP measurement could be optimized by using (1) at least five stimuli per session, (2) a minimum of 110% resting motor threshold as stimulation intensity, (3) a minimum of 4 s inter-trial interval and increasing the interval up to 20 s, (4) a figure-of-eight coil and (5) a monophasic waveform. MEPs can be reliably operationalized.

Retest reliability of repetitive transcranial magnetic stimulation over the healthy human motor cortex: a systematic review and meta-analysis.

Introduction: Repetitive transcranial magnetic stimulation (rTMS) is used to induce long-lasting changes (aftereffects) in cortical excitability, which are often measured via single-pulse TMS (spTMS) over the motor cortex eliciting motor-evoked potentials (MEPs). rTMS includes various protocols, such as theta-burst stimulation (TBS), paired associative stimulation (PAS), and continuous rTMS with a fixed frequency. Nevertheless, subsequent aftereffects of rTMS are variable and seem to fail repeatability. We aimed to summarize standard rTMS procedures regarding their test-retest reliability. Hereby, we considered influencing factors such as the methodological quality of experiments and publication bias. Methods: We conducted a literature search via PubMed in March 2023. The inclusion criteria were the application of rTMS, TBS, or PAS at least twice over the motor cortex of healthy subjects with measurements of MEPs via spTMS as a dependent variable. The exclusion criteria were measurements derived from the non-stimulated hemisphere, of non-hand muscles, and by electroencephalography only. We extracted test-retest reliability measures and aftereffects from the eligible studies. With the Rosenthal fail-safe N, funnel plot, and asymmetry test, we examined the publication bias and accounted for influential factors such as the methodological quality of experiments measured with a standardized checklist. Results: A total of 15 studies that investigated test-retest reliability of rTMS protocols in a total of 291 subjects were identified. Reliability measures, i.e., Pearson's r and intraclass correlation coefficient (ICC) applicable from nine studies, were mainly in the small to moderate range with two experiments indicating good reliability of 20 Hz rTMS (r = 0.543) and iTBS (r = 0.55). The aftereffects of rTMS procedures seem to follow the heuristics of respective inhibition or facilitation, depending on the protocols' frequency, and application pattern. There was no indication of publication bias and the influence of methodological quality or other factors on the reliability of rTMS. Conclusion: The reliability of rTMS appears to be in the small to moderate range overall. Due to a limited number of studies reporting test-retest reliability values and heterogeneity of dependent measures, we could not provide generalizable results. We could not identify any protocol as superior to the others.

Limited evidence for reliability of low and high frequency rTMS over the motor cortex.

OBJECTIVE: The aim of this study was to investigate the reliability of low-frequency and high-frequency repetitive transcranial magnetic stimulation (rTMS) on healthy individuals over the motor cortex. A secondary outcome was the assessment if low-frequency rTMS results in inhibition and high-frequency rTMS results in facilitation. METHODS: In this experiment, 30 healthy participants received on four consecutive days one session each with application of 1 Hz or 20 Hz rTMS over the left motor cortex. 1 Hz and 20 Hz were applied in alternating order, whereby the starting frequency was randomized. Motor evoked potentials (MEPs) were measured before and after each session. Reliability measures were intraclass and Pearson's correlation coefficient (ICC and r). RESULTS: ICCs and r values were low to moderate. Notably, within subgroups of less confounded measures, we found good r values for 20 Hz rTMS. The group-level analysis did not demonstrate a clear low-frequency inhibition and high-frequency facilitation pattern. At the single-subject level, only one participant exhibited significant changes consistent with the expected pattern, with concurrent decreases in MEPs following 1 Hz sessions and increases following 20 Hz sessions. CONCLUSION: The investigated neuromodulatory protocols show low to moderate reliability. Results are questioning the low-frequency inhibition and high-frequency facilitation pattern. SIGNIFICANCE: Methodological improvements for the usage of rTMS are necessary to increase validity and reliability of non-invasive brain stimulation.

Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Depression in the Elderly: A Retrospective Natural Analysis.

INTRODUCTION: Depression in the elderly is an understudied condition. Psychopharmacological and psychotherapeutic approaches suffer from specific difficulties with this patient group. Brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) offer a therapeutic alternative. rTMS remains understudied in this age group when compared with younger patients. METHODS: A cohort of 505 patients with depression was analyzed in retrospect concerning their response to rTMS treatment. A total of 15.5% were 60 years old or older, defined as the elderly group of depressed patients. The majority of these were treated with high-frequency protocols over the left dorsolateral prefrontal cortex (DLPFC). For group comparisons, we used Student t-tests or chi-square-tests, depending on the scales of measurement. As measures for effect size, we used Cohen's d for the relative and absolute change in the HDRS total score. RESULTS: Groups did not differ significantly with respect to baseline depression severity or treatment parameters. In the group of elderly patients, a higher number of females were present. Groups did not differ significantly with respect to treatment efficacy, as indicated by the absolute and relative changes in the HDRS-21 sum score. Elderly patients tended to take higher numbers of mood stabilizers. Elderly patients showed a significantly superior reduction for the item "appetite" and a superior reduction tending towards significance for the item "work and interests". CONCLUSIONS: Antidepressant rTMS treatment showed comparable efficacy for patients above 60 years to that in younger patients. Differences between the age groups concerning amelioration of distinct HDRS single items deserve further investigation.

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT).

BACKGROUND: Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. METHODS: Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. DISCUSSION: The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. TRIAL REGISTRATION: ClinicalTrials.gov NCT04663828 . The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.

Neural Responses to a Working Memory Task in Acute Depressed and Remitted Phases in Bipolar Patients.

(1) Cognitive impairments such as working memory (WM) deficits are amongst the most common dysfunctions characterizing bipolar disorder (BD) patients, severely contributing to functional impairment. We aimed to investigate WM performance and associated brain activation during the acute phase of BD and to observe changes in the same patients during remission. (2) Frontal brain activation was recorded using functional near-infrared spectroscopy (fNIRS) during n-back task conditions (one-back, two-back and three-back) in BD patients in their acute depressive (n = 32) and remitted (n = 15) phases as well as in healthy controls (n = 30). (3) Comparison of BD patients during their acute phase with controls showed a trend (p = 0.08) towards lower dorsolateral prefrontal cortex (dlPFC) activation. In the remitted phase, BD patients showed lower dlPFC and ventrolateral prefrontal cortex (vlPFC) activation (p = 0.02) compared to controls. No difference in dlPFC and vlPFC activation between BD patients' phases was found. (4) Our results showed decreased working memory performance in BD patients during the working memory task in the acute phase of disease. Working memory performance improved in the remitted phase of the disease but was still particularly attenuated for the more demanding conditions.

Tinnitus Is Marginally Associated with Body Mass Index, Heart Rate and Arterial Blood Pressure: Results from a Large Clinical Sample.

INTRODUCTION: This study aimed to explore whether body mass index (BMI), systolic blood pressure (RR syst), diastolic blood pressure (RR diast) or heart rate (HR) are associated with tinnitus status and/or severity. METHODS: To that end, we evaluated the influence of tinnitus status and Tinnitus Handicap Inventory (THI) score on BMI, RR syst, RR diast and HR by comparing data from a large sample of patients presenting to a specialized tertiary referral clinic (N = 1066) with data from a population-based control group (N = 9885) by means of linear models. RESULTS: Tinnitus patients had a significantly lower BMI and higher RR syst, RR diast and HR than non-tinnitus patients; however, the contribution of the case-control status to R2 was very small (0.1%, 0.7%, 1.4% and 0.4%, respectively). BMI had little predictive power for the THI score (higher BMI scores were related to higher THI scores; R2 = 0.5%) and neither RR syst, RR diast, nor HR showed a statistically significant association with THI. DISCUSSION: Our findings suggest that HR, RR and BMI are at most marginally associated with tinnitus status and severity.

Cognitive Behavioral Group Therapy for Chronic Tinnitus in a German Tertiary Clinical Real-World Setting.

Cognitive behavioral therapy (CBT) was shown to be effective in reducing tinnitus-related distress in numerous controlled trials. Real-world data from tinnitus treatment centers are an important addition to controlled trials for demonstrating the ecological validity of the results from the randomized controlled trials. Thus, we provided the real-world data of 52 patients participating in CBT group therapies during the time period from 2010 to 2019. The groups consisted of five to eight patients with typical CBT content such as counseling, relaxation, cognitive restructuring, attention training, etc. applied through 10-12 weekly sessions. The mini tinnitus questionnaire, different tinnitus numeric rating scales and the clinical global impression were assessed in a standardized way and were analyzed retrospectively. All outcome variables showed clinically relevant changes from before to after the group therapy, which were still evident in the follow-up visit after three months. Amelioration of distress was correlated to all numeric rating scales, including tinnitus loudness but not annoyance. The observed positive effects were in a similar range as effects of controlled and uncontrolled studies. Somewhat unexpected was the observed reduction in loudness, which was associated with distress and the missing association of changes in distress with annoyance as it is generally assumed that standard CBT concepts reduce annoyance and distress, but not tinnitus loudness. Apart from confirming the therapeutic effectiveness of CBT in real-world settings, our results highlight the need for a clear definition/operationalization of outcome measures when investigating psychological interventions of tinnitus.

Pilot study of a smartphone-based tinnitus therapy using structured counseling and sound therapy: A multiple-baseline design with ecological momentary assessment.

Tinnitus affects a considerable part of the population and develops into a severe disorder in some sufferers. App-based interventions are able to provide low-threshold, cost-effective, and location-independent care for tinnitus patients. Therefore, we developed a smartphone app combining structured counseling with sound therapy and conducted a pilot study to evaluate treatment compliance and symptom improvement (trial registration: DRKS00030007). Outcome variables were Ecological Momentary Assessment (EMA) measured tinnitus distress and loudness and Tinnitus Handicap Inventory (THI) at baseline and final visit. A multiple-baseline design with a baseline phase (only EMA) followed by an intervention phase (EMA and intervention) was applied. 21 patients with chronic tinnitus (≥ 6 months) were included. Overall compliance differed between modules (EMA usage: 79% of days, structured counseling: 72%, sound therapy: 32%). The THI score improved from baseline to final visit indicating a large effect (Cohens d = 1.1). Tinnitus distress and loudness did not improve significantly from baseline phase to the end of intervention phase. However, 5 of 14 (36%) improved clinically meaningful in tinnitus distress (ΔDistress ≥ 10) and 13 of 18 (72%) in THI score (ΔTHI ≥ 7). The positive relationship between tinnitus distress and loudness weakened over the course of the study. A trend but no level effect for tinnitus distress could be demonstrated by a mixed effect model. The improvement in THI was strongly associated with the improvement scores in EMA of tinnitus distress (r = -0.75; 0.86). These results indicate that app-based structured counseling combined with sound therapy is feasible, has an impact on tinnitus symptoms and reduces distress for several patients. In addition, our data suggest that EMA could be used as a measurement tool to detect changes in tinnitus symptoms in clinical trials as has already been shown in other areas of mental health research.

Effect of prefrontal transcranial direct current stimulation on sexual arousal: A proof of concept study.

There is preliminary evidence that high-frequency repetitive transcranial magnetic stimulation targeting the right dorsolateral prefrontal cortex (DLPFC) could reduce cue-induced sexual arousal. Here, we aimed to replicate this finding by using transcranial direct current stimulation (tDCS). In a randomized, double-blind, sham-controlled crossover study design, 24 healthy male participants received anodal tDCS over right DLPFC, anodal tDCS over left DLPFC, and sham tDCS with exposure to neutral and sexual video cues before and after each intervention. None of the interventions significantly reduced subjective sexual arousal. Stimulation parameters should be varied in further studies to identify factors relevant to the intended effect.

Activate & fire: a feasibility study in combining acoustic stimulation and continuous theta burst stimulation in chronic tinnitus.

BACKGROUND: Low frequency repetitive transcranial magnetic stimulation (rTMS) is commonly used to inhibit pathological hyperactivity of the auditory cortex in tinnitus. Novel and supposedly superior and faster inhibitory protocols such as continuous theta burst stimulation (cTBS) were examined as well, but so far there is not sufficient evidence for a treatment application in chronic tinnitus. rTMS effects in general are dependent on the brain state immediate before stimulation. This feasibility study was designed based on the concept to shift the pathological intrinsic brain state of tinnitus patients via acoustic stimulation ("activate") and induce inhibitory effects via cTBS ("fire"). METHODS: Seven tinnitus patients with response in residual inhibition received 10 consecutive daily sessions of a combinatory treatment comprised of 3-minute acoustic stimulation with white noise followed by 600 pulses of cTBS over the left temporo-parietal cortex (activate & fire). A control group of 5 patients was treated parallel to the activate & fire data collection with 10 sessions á 3000 pulses of 1 Hz rTMS over the left temporo-parietal cortex. RESULTS: The activate & fire protocol was well tolerated except in one patient with tinnitus loudness increase. This patient was excluded from analyses. No statistical superiority of the activate & fire treatment approach in alleviating tinnitus-related symptoms was evident. Power calculations showed an effect size of 0.706 and a needed sample size of 66 for statistical significant group differences. On a descriptive level the activate & fire group demonstrated a stronger decrease in tinnitus-related symptoms. CONCLUSION: The present feasibility study showed that combining acoustic stimulation with magnetic brain stimulation may be well-tolerable in the majority of patients and represents a promising treatment approach for tinnitus by hypothetically alter the intrinsic state prior to brain stimulation.