RTMS parameters in tinnitus trials: a systematic review.
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ABSTRACT:
SUBMITTER: Schoisswohl S
PROVIDER: S-EPMC6704094 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
Publications
RTMS parameters in tinnitus trials: a systematic review.
Schoisswohl Stefan S Agrawal Kushal K Simoes Jorge J Neff Patrick P Schlee Winfried W Langguth Berthold B Schecklmann Martin M
Scientific reports 20190821 1
Over the past few years extensive body of research was produced investigating the effects of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic tinnitus with heterogeneous results. This heterogeneity is exemplified by two recently published large-scale clinical trials reporting different outcomes. Technical aspects of rTMS were suspected as a potential source for this incongruency. The aim of this systematic review is to examine the overall efficacy as well as to id ...[more]
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Project description:There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus.Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded.Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used.Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments.The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.
| S-EPMC4888312 | biostudies-other
Project description:BackgroundComplementary and alternative medicine (CAM) has frequently been used to treat tinnitus, and acupuncture is a particularly popular option. The objective of this review was to assess the evidence concerning the effectiveness of acupuncture as a treatment for tinnitus.MethodsFourteen databases were searched from the dates of their creation to July 4th, 2012. Randomized clinical trials (RCTs) were included if acupuncture was used as the sole treatment. The Cochrane risk of bias tool was used to assess the risk of bias.ResultsA total of 9 RCTs met all the inclusion criteria. Their methodological quality was mostly poor. Five RCTs compared the effectiveness of acupuncture or electroacupuncture with sham acupuncture for treating tinnitus. The results failed to show statistically significant improvements. Two RCTs compared a short one-time scalp acupuncture treatment with the use of penetrating sham acupuncture at non-acupoints in achieving subjective symptom relief on a visual analog scale; these RCTs demonstrated significant positive effects with scalp acupuncture. Two RCTs compared acupuncture with conventional drug treatments. One of these RCTs demonstrated that acupuncture had statistically significant effects on the response rate in patients with nervous tinnitus, but the other RCT did not demonstrate significant effects in patients with senile tinnitus.ConclusionsThe number, size and quality of the RCTs on the effectiveness of acupuncture for the treatment of tinnitus are not sufficient for drawing definitive conclusions. Further rigorous RCTs that overcome the many limitations of the current evidence are warranted.
| S-EPMC3493359 | biostudies-literature
Project description:BackgroundTreatment effects of electroacupuncture for patients with subjective tinnitus has yet to be clarified.ObjectivesTo assess the effect of electroacupuncutre for alleviating the symptoms of subjective tinnitus.MethodsExtensive literature searches were carried out in three English and four Chinese databases (PubMed, EMBASE, Cochrane Library, CNKI, Wanfang Chinese Digital Periodical and Conference Database, VIP, and ChiCTR).The date of the most recent search was 1 June 2014. Randomized controlled trials (RCTs) or quasi-RCTs were included. The titles, abstracts, and keywords of all records were reviewed by two authors independently. The data were collected and extracted by three authors. The risk of bias in the trials was assessed in accordance with the Cochrane Handbook, version 5.1.0. (http://www.handbook.cochrane.org). Eighty-nine studies were retrieved. After discarding 84 articles, five studies with 322 participants were identified. Assessment of the methodological quality of the studies identified weaknesses in all five studies. All studies were judged as having a high risk of selection and performance bias. The attrition bias was high in four studies. Incompleteness bias was low in all studies. Reporting bias was unclear in all studies. Because of the limited number of trials included and the various types of interventions and outcomes, we were unable to conduct pooled analyses.ConclusionsDue to the poor methodological quality of the primary studies and the small sample sizes, no convincing evidence that electroacupuncture is beneficial for treating tinnitus could be found. There is an urgent need for more high-quality trials with large sample sizes for the investigation of electroacupuncture treatment for tinnitus.
| S-EPMC4777560 | biostudies-literature
Project description:BackgroundSubjective idiopathic tinnitus is an intrusive, distracting, and potentially disabling disorder characterized by phantom perception of sounds. Although tinnitus has no approved pharmacologic treatment, recent evidence supports the use of repetitive transcranial magnetic stimulation (rTMS) to alleviate tinnitus symptoms.Objective/hypothesisRepetitive TMS delivered over the middle superior temporal gyrus (STG) may alter ratings of tinnitus awareness and annoyance more than loudness due to change in attentional processing. STG has reciprocal connections to regions of the prefrontal cortex that mediate attention. To probe the hypothesized influence of STG stimulation on attention, a subset of patients with tinnitus enrolled in an rTMS clinical trial [n = 12, 9 male, mean (sd) age = 49 (15) years] underwent an attentional conflict task before and after rTMS treatment in a repeated-measures functional magnetic resonance imaging (fMRI) study.MethodsThe Multi-Source Interference Task (MSIT), a Stroop-based visual attentional conflict fMRI task, was used to map participants' neural processing of attentional conflict prior to rTMS intervention (Baseline) and after three rTMS intervention arms: Sham, 1 Hz, and 10 Hz (four sessions per arm, 1800 pulses per session, delivered @110% of the motor threshold over the posterior superior temporal gyrus).ResultsAll measures of tinnitus severity (awareness, loudness, and annoyance) improved with 1 Hz rTMS intervention; however, the greatest and most robust changes were observed for ratings of tinnitus awareness (mean 16% reduction in severity from Baseline, p < 0.01). The MSIT elicited a similar pattern of neural activation among tinnitus participants at Baseline compared to an independent sample of 43 healthy comparison adults (r = 0.801, p = 0.001). Linear regression with bootstrap resampling showed that greater recruitment of bilateral prefrontal and bilateral parietal regions by MSIT at Baseline corresponded with poorer treatment response. Individual regions' activities explained 37-67% variance in participant treatment response, with left dorsolateral prefrontal cortex's MSIT activity at Baseline explaining the greatest reduction in tinnitus awareness following 1 Hz stimulation. Although left dorsolateral prefrontal cortex activity at Baseline also predicted reduction in tinnitus loudness and annoyance (∼50% variance explained), these symptoms were more strongly predicted by right middle occipital cortex (∼70% variance explained) - suggesting that the neural predictors of symptom-specific treatment outcomes may be dissociable.ConclusionThese candidate neural reactivity markers of treatment response have potential clinical value in identifying tinnitus sufferers who would or would not therapeutically benefit from rTMS intervention.
| S-EPMC5600281 | biostudies-literature
Project description:Objectives: To systematically review studies on the effect of treatment of subjective tinnitus in children. Data Sources: We searched for studies in MEDLINE and EMBASE databases, after which additional studies were hand searched using Scopus databases. The methods are described in the study protocol, which has been registered in the PROSPERO register. PRISMA guidelines were followed in the reporting of this study. Eligibility Criteria: We considered for inclusion randomized controlled trials (RCTs), observational studies, case reports, and case series, with tinnitus as primary outcome in children (0-18 years old) with acute or chronic subjective tinnitus. We excluded studies in which both children and adults participated but outcomes were not specifically reported for children, as well as animal studies, studies with a non-original study design and studies about children with pulsatile or objective tinnitus. Data Selection: Two reviewers independently assessed studies for eligibility and quality, collected and extracted data. Statistical analyses were performed in case of homogeneous outcomes. Results: The search yielded a total of 4,447 studies. Of these, 147 eligible studies were selected. One case report and five observational studies met the eligibility criteria. Three studies applied counseling and (simplified-)TRT and reported improvement in tinnitus outcome in 68 out of 82 children after 3-6 months of treatment. Two studies used pharmacological treatments and reported improvement in 74 out of 86 patients after 10 days to 3 months of treatment. One study reported the outcome of biofeedback therapy, describing an improvement in tinnitus loudness and annoyance after 2 months of treatment. Conclusion: Due to the high risk of bias of the included studies, we cannot determine the effectiveness of the treatment of subjective tinnitus in children. Also, owing to brief follow-up periods, it is not possible to draw conclusions regarding long-term effects. Randomized controlled trials with longer follow-up periods are necessary to provide substantial evidence of the effects of therapies for children affected by tinnitus. https://www.crd.york.ac.uk/prospero/ Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier [CRD42020178134].
| S-EPMC8460757 | biostudies-literature
Project description:ObjectiveTinnitus is a condition that causes distress and impairment across cognitive, functional, and psychiatric spectra. In the psychiatric realm, tinnitus has long been associated with depression. To better characterize the co-occurrence of depression and tinnitus, we performed a systematic review of the prevalence of depression among patients with tinnitus.Data sourcesWe comprehensively examined original studies reporting the prevalence of depression in adult populations with tinnitus, as indexed in the PubMed and Web of Science databases and published from January 2006 to August 2016.Review methodsAll identified articles were reviewed independently by 2 researchers, with a third reviewer for adjudication. Included studies were evaluated for threats to validity across 3 domains-representativeness, response rate, and ascertainment of outcome-on a 4-point modified Newcastle-Ottawa Quality Assessment Scale.ResultsTwenty-eight studies were included, representing 15 countries and 9979 patients with tinnitus. Among the included studies, the median prevalence of depression was 33%, with an interquartile range of 19% to 49% and an overall range of 6% to 84%. Studies were high quality overall, with a mean score of 3.3 (SD = 0.76), and 89% utilized a validated tool to ascertain depression.ConclusionsWe conducted one of the largest contemporary comprehensive reviews, which suggests a 33% prevalence of depression among patients with tinnitus. Our review reaffirms that a substantial proportion of patients with tinnitus have depression, and we recommend that all who treat tinnitus should screen and treat their patients for depression, if present.
| S-EPMC7721477 | biostudies-literature
Project description:Recent research indicates that tinnitus is related to alterations of neural networks including temporal, parietal, and prefrontal brain regions. The current study examines a rTMS protocol which targets three central nodes of these networks in a two-arm randomized parallel group trial. Overall, 49 patients with chronic tinnitus were randomized to receive either triple-site stimulation (left dorsolateral prefrontal stimulation, 1000 pulses, 20 Hz plus left and right temporoparietal stimulation, 1000 pulses each, 1 Hz) or single-site stimulation (left temporoparietal stimulation, 3000 pulses, 1 Hz). Both groups were treated in ten sessions. Tinnitus severity as measured by the tinnitus questionnaire was assessed before rTMS (day1), after rTMS (day12) and at two follow-up visits (day 90 and day 180). The triple-site protocol was well tolerated. There was a significant reduction in tinnitus severity for both treatment groups. The triple-site group tended to show a more pronounced treatment effect at day 90. However, the measurement time point x group interaction effect was not significant. The current results confirm former studies that indicated a significant reduction of tinnitus severity after rTMS treatment. No significant superiority of the multisite protocol was observed. Future approaches for the enhancement of treatment effects are discussed.
| S-EPMC4772792 | biostudies-literature
Project description:(1) Background: Psychological interventions are effective in alleviating neuropsychiatric symptoms, though results can vary between patients. Repetitive transcranial magnetic stimulation (rTMS) has been proven to improve clinical symptoms and cognition. It remains unclear whether rTMS can augment the efficacy of psychological interventions. (2) Methods: We examined the effects of rTMS combined with psychological interventions on clinical, functional, and cognitive outcomes from randomized controlled trials conducted in healthy and clinical populations. We searched PubMed, EMBASE, Cochrane Library, and PsycINFO databases up to April 2023. (3) Results: Twenty-seven studies were ultimately included. Compared to sham rTMS combined with psychological interventions, active rTMS combined with psychological interventions significantly improved overall clinical symptoms (k = 16, SMD = 0.31, CIs 0.08 to 0.54, p < 0.01). We found that 10 or more sessions of rTMS combined with cognitive behavioural therapy significantly improved clinical outcomes overall (k = 3, SMD = 0.21, CIs 0.05 to 0.36, Z = 2.49, p < 0.01). RTMS combined with cognitive training (CT) significantly improved cognition overall compared to sham rTMS combined with CT (k = 13, SMD = 0.28, CIs 0.15 to 0.42, p < 0.01), with a significant effect on global cognition (k = 11, SMD = 0.45, CIs 0.21 to 0.68, p < 0.01), but not on the other cognitive domains. (4) Conclusion: The current results provide preliminary support for the augmentation effects of active rTMS on clinical and cognitive outcomes across diverse populations. Future clinical trials are required to confirm these augmentation effects for specific psychological interventions in specific clinical populations.
| S-EPMC10741493 | biostudies-literature
Project description:To systematically review studies of the epidemiology of tinnitus and hyperacusis in children and young people, in order to determine the methodological differences implicated in the variability of prevalence estimates and the influence of population characteristics on childhood tinnitus and hyperacusis.Articles were retrieved from PubMed, EMBASE and Scopus databases and from the relevant reference lists using the methods described in the study protocol, which has previously been published. Reporting Items for Systematic Review (PRISMA) guidelines were followed.Studies addressing childhood prevalence, for example, children and young people aged 5-19 years.2 reviewers independently assessed the studies for eligibility, extracted data and assessed study consistency. Owing to the heterogeneity in the methodologies among the reported studies, only narrative synthesis of the results was carried out.Having identified 1032 publications, 131 articles were selected and 25 articles met the inclusion criteria and had sufficient methodological consistency to be included. Prevalence estimates of tinnitus range from 4.7% to 46% in the general paediatric population and among children with normal hearing, and from 23.5% to 62.2% of population of children with hearing loss. Reported prevalence ranged from 6% to 41.9% when children with hearing loss and normal hearing were both included. The prevalence of hyperacusis varied from 3.2% to 17.1%.Data on prevalence vary considerably according to the study design, study population and the research question posed. The age range of children studied was varied and a marked degree of variation between definitions (tinnitus, hyperacusis) and measures (severity, perception, annoyance) was observed. The lack of consistency among studies indicates the necessity of examining the epidemiology of tinnitus and hyperacusis in children and adolescents with a set of standardised criteria.CRD42014013456.
| S-EPMC4893873 | biostudies-other
Project description:Background and hypothesisCurrent treatments for schizophrenia are only partially effective, and there are no medications for negative symptoms or cognitive impairment. Neuromodulation, such as repetitive transcranial magnetic stimulation (rTMS), has potential as a novel intervention for schizophrenia. Prior to clinical use, rTMS should have demonstrated safety in a large schizophrenia population. However, the safety profile of rTMS in schizophrenia is not well characterized, and regulatory agencies have expressed concern about safety in this population.Study designWe conducted a systematic review with meta-analysis of rTMS studies in schizophrenia. We searched PubMed, the Cochrane Library, PsycINFO, and Science Citation Index Expanded for rTMS studies in schizophrenia that reported adverse effects. We extracted the number of participants who experienced an adverse effect and calculated the prevalence of each adverse effect for active or sham rTMS. We tested the difference between the prevalence of events in the active and sham conditions. We assessed risk of bias using the Cochrane Handbook.Study resultsThe initial search identified 1472 studies. After screening, 261 full-text studies were assessed, and 126 met inclusion criteria (N = 4122 total subjects). The prevalence of headache or scalp pain, dizziness or syncope, facial twitching, and nausea was higher for active rTMS compared to sham (P < .05). The prevalence of all other adverse effects, including seizure, was not different between active and sham rTMS.ConclusionsrTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse effects, including seizure, compared to the general population.
| S-EPMC11908856 | biostudies-literature