Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial

Cardon, Emilie; Rompaey, Vincent Van; Jacquemin, Laure; Mertens, Griet; Vermeersch, Hanne; Joossen, Iris; Beyers, Jolien; Vanderveken, Olivier M.; Heyning, Paul Van de; Topsakal, Vedat; Gilles, Annick

doi:10.1186/s13063-019-3594-y

Cited by 6 publications

(8 citation statements)

References 54 publications

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“…A more extensive dataset with regards to tinnitus characteristics and hearing status was available in the research database of the ENT department (OpenClinica LLC, an electronic CRF application), including 622 patients who were enrolled in a clinical study [e.g. 21,[22][23][24][25][26].…”

Section: Methodsmentioning

confidence: 99%

Hyperacusis: demographic, audiological, and clinical characteristics of patients at the ENT department

Jacquemin

Cardon

Michiels

et al. 2022

Eur Arch Otorhinolaryngol

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Purpose: To document whether patients with and without hyperacusis differ from each other on demographic, audiological and clinical characteristics. Methods:Based on the Hyperacusis Questionnaire's (HQ) cut-off (HQ > 28), a total of 2301 participants were divided into patients with and without hyperacusis. Demographic data, scores on self-reported questionnaires (Tinnitus Functional Index (TFI), Visual Analogue Scale of tinnitus loudness (VASloudness), Hospital Anxiety Depression Scale (HADS)) and audiological parameters were retrospectively analysed to determine differential factors between the two groups.Results: In total, 10,9 % of the patients was classified as hyperacusis patients (n = 251). They reported a significant, higher tinnitus severity (mean difference of 19 points on TFI) and mental distress (mean difference of 4 points on the HADS subscales) (p < .001) than patients without hyperacusis. Moreover, this group consisted of more women (45% % in hyperacusis group vs. 35 % in non-hyperacusis group) and women scored significantly higher on the HQ (p < .001) and TFI (p < .01). Conclusion:Patients with hyperacusis have distinctive characteristics. The presence of hyperacusis in combination with tinnitus can indicate a higher need for psychoeducation. Patients that present themselves with hyperacusis without tinnitus complaints remain a minority, yet might be underdiagnosed. Hence, future studies should disentangle tinnitus from hyperacusis. In clinical practice, greater efforts are required to increase knowledge about hyperacusis as a primary or secondary complaint and to provide individualized treatment for these patients.

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Section: Methodsmentioning

confidence: 99%

Hyperacusis: demographic, audiological, and clinical characteristics of patients at the ENT department

Jacquemin

Cardon

Michiels

et al. 2022

Eur Arch Otorhinolaryngol

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“…This analysis was performed on a dataset obtained in a previous study that originated in a clinical setting ( Jacquemin et al 2021 ). A sham-controlled trial using this HD-tDCS method is currently ongoing ( Cardon et al 2019 ), and results from this trial will be used to further validate the model. In the absence of a sham arm, it is currently not possible to distinguish naturally occurring fluctuations of tinnitus severity from specific effects of the HD-tDCS.…”

Section: Discussionmentioning

confidence: 99%

“…More recently published placebo-controlled studies have led to conflicting results, with only some authors reporting significant efficacy of tDCS treatment for tinnitus ( Shekhawat et al 2013 ; Teismann et al 2014 ; Pal et al 2015 ; Forogh et al 2016 ; Hyvärinen et al 2016 ). Varying protocols and limited sample sizes make definitive conclusions about the efficacy of tDCS for tinnitus rather elusive ( Lefaucheur et al 2017 ; Cardon et al 2019 ). Despite the large degree of uncertainty regarding effective outcomes of this technique, many centers currently offer some form of tDCS as an experimental tinnitus treatment.…”

Section: Introductionmentioning

confidence: 99%

Random Forest Classification to Predict Response to High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief: A Preliminary Feasibility Study

et al. 2022

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Objectives: Transcranial direct current stimulation (tDCS) of the right dorsolateral prefrontal cortex has been hypothesized to reduce tinnitus severity by modifying cortical activity in brain regions associated with the perception of tinnitus. However, individual response to tDCS has proven to be variable. We investigated the feasibility of using random forest classification to predict the response to high-definition (HD) tDCS for tinnitus relief.Design: A retrospective analysis was performed on a dataset consisting of 99 patients with subjective tinnitus receiving six consecutive sessions of HD-tDCS at the Antwerp University Hospital. A baseline assessment consisted of pure-tone audiometry and a set of questionnaires including the Tinnitus Functional Index (TFI), Hospital Anxiety and Depression Scale, and Edinburgh Handedness Inventory. Random forest classification was applied to predict, based on baseline questionnaire scores and hearing levels, whether each individual responded positively to the treatment (defined as a decrease of at least 13 points on the TFI). Further testing of the model was performed on an independent cohort of 32 patients obtained from the tinnitus center at the University of Regensburg.Results: Twenty-four participants responded positively to the HD-tDCS treatment. The random forest classifier predicted treatment response with an accuracy of 85.71% (100% sensitivity, 81.48% specificity), significantly outperforming a more traditional logistic regression approach. Performance of the classifier on an independent cohort was slightly but not significantly above chance level (71.88% accuracy, 66.67% sensitivity, 73.08% specificity). Feature importance analyses revealed that baseline tinnitus severity, co-occurrence of depressive symptoms and handedness were the most important predictors of treatment response. Baseline TFI scores were significantly higher in responders than in nonresponders. Conclusions:The proposed random forest classifier predicted treatment response with a high accuracy, significantly outperforming a more traditional statistical approach. Machine learning methods to predict treatment response might ultimately be used in a clinical setting to guide targeted treatment recommendations for individual tinnitus patients.

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“…The full protocol of this clinical trial has been published elsewhere. 53 The study has been registered at ClinicalTrials.gov (protocol number: NCT03754127) since 22 November 2018.…”

Section: Methodsmentioning

confidence: 99%

Dual-site transcranial direct current stimulation to treat tinnitus: a randomized controlled trial

Cardon

Jacquemin

Vermeersch

et al. 2022

Brain

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Transcranial direct current stimulation (tDCS) has been proposed as a potential intervention for subjective tinnitus, but supporting evidence remains limited. We aimed to investigate the effect of anodal high-definition tDCS of the left temporal area and right dorsolateral prefrontal cortex on tinnitus severity. This double-blind randomized controlled trial included 77 patients (age range 18–79, 43 male) with chronic subjective tinnitus as their primary complaint. Thirty-eight subjects received six consecutive sessions of dual-site sequential high-definition-tDCS with electrodes positioned over the left temporal area and right dorsolateral prefrontal cortex. Both areas were stimulated for 15 min per session, with total stimulation time amounting to 30 min. Thirty-nine subjects received sham stimulation. The primary outcome measure was the change in tinnitus severity, as evaluated by the Tinnitus Functional Index, from baseline to a follow-up visit at 8 ± 2 weeks after treatment completion. Secondary outcomes included changes in perceived tinnitus loudness, as measured with a visual analogue scale and a tinnitus matching procedure, as well as scores on the Hospital Anxiety and Depression Scale, and the Hyperacusis Questionnaire. No differences in Tinnitus Functional Index change scores were identified between the active treatment and sham control groups (linear regression: P = 0.86). The Tinnitus Functional Index scores decreased significantly over time in both groups (P = 0.0012), indicating the presence of a considerable placebo effect. These change scores were significantly influenced by sex (linear regression: P = 0.037) and baseline symptoms of anxiety (linear regression: P = 0.049) in both groups. In general, Tinnitus Functional Index scores decreased more profoundly in males and in subjects with a higher degree of anxiety at baseline. None of the included secondary measures differed significantly between experimental arms. Our results suggest that dual-site sequential high-definition-tDCS of the left temporal area and right dorsolateral prefrontal cortex does not alleviate tinnitus severity. Interestingly, in our study population, fluctuations in tinnitus severity were influenced by gender and concurrent mental condition. It is therefore important to take these factors into account when conducting or planning randomized controlled trials in tinnitus populations.

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Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial

Cited by 6 publications

References 54 publications

Hyperacusis: demographic, audiological, and clinical characteristics of patients at the ENT department

Hyperacusis: demographic, audiological, and clinical characteristics of patients at the ENT department

Random Forest Classification to Predict Response to High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief: A Preliminary Feasibility Study

Dual-site transcranial direct current stimulation to treat tinnitus: a randomized controlled trial

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