Evidence map›Paper›PMID 31370873›Full record

ArticleTrials2019

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.

E Cardon, V Van Rompaey, L Jacquemin, G Mertens, H Vermeersch, I Joossen, J Beyers, O M Vanderveken, P Van de Heyning, V Topsakal and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03754127 (A Comparative, Randomized Trial on HD-tDCS and Sham Control Group), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03754127 nacompletednot on this map

A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.

TypeinterventionalSponsorUniversity Hospital, AntwerpRan2019 to 2022Enrolled81ConditionsTinnitusArmstDCS, sham tDCS
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Hyperacusis: demographic, audiological, and clinical characteristics of patients at the ENT department.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Article
  3. Long-term effects of a single psycho-educational session in chronic tinnitus patients.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

E CardonDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium. Emilie.Cardon@uantwerpen.be.ORCID http://orcid.org/0000-0002-2105-5989
V Van RompaeyDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
L JacqueminDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
G MertensDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
H VermeerschDepartment of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium.
I JoossenDepartment of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium.
J BeyersDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
O M VandervekenDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
P Van de HeyningDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
V TopsakalDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
A GillesDepartment of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
University of Antwerp · BEAntwerp University Hospital · BEUniversity College Ghent · BE

Funding

Fonds Wetenschappelijk Onderzoek T001618N
6 · The paper itself

Abstract

backgroundChronic tinnitus is a highly prevalent symptom, with many patients reporting considerable effects of tinnitus on quality of life. No clear evidence-based treatment options are currently available. While counseling-based methods are valuable in some cases, they are not sufficiently effective for all tinnitus patients. Neuromodulation techniques such as high-definition transcranial direct current stimulation (HD-tDCS) are proposed to have positive effects on tinnitus severity but, to date, these effects have not been proven conclusively. The proposed trial will investigate the hypothesis that chronic tinnitus patients receiving HD-tDCS will report a positive effect on the impact of tinnitus on daily life, as compared to patients receiving sham stimulation.

methodsThis study proposes a randomized, double-blind, placebo-controlled trial with parallel group design. A total of 100 chronic tinnitus patients will be randomly allocated to an experimental group or a sham group, with allocation stratified according to gender and tinnitus severity. Patient and researcher will be blinded to the patient's allocation. Patients will undergo six sessions of sequential dual-site HD-tDCS of the left temporal area and the right dorsolateral prefrontal cortex. Evaluations will take place at baseline, immediately following treatment, and at three and six months after the start of the therapy. The primary outcome measure is the change in Tinnitus Functional Index (TFI) score. Secondary outcome measures include audiological measurements, cortical auditory evoked potentials, the Repeatable Battery for the Assessment of Neuropsychological Status adjusted for hearing-impaired individuals (RBANS-H), and supplementary questionnaires probing tinnitus severity and additional symptoms. By use of a linear regression model, the effects of HD-tDCS compared to sham stimulation will be assessed. DISCUSSION: The objective of this study is to evaluate whether HD-tDCS can reduce the impact of tinnitus on daily life in chronic tinnitus patients. To date, published trials on the effects of HD-tDCS on tinnitus suffer from a lack of standardization and few randomized controlled trials exist. The proposed study will be the first adequately powered trial to investigate the effects of sequential dual-site HD-tDCS on tinnitus severity.

trial registrationClinicalTrials.gov, NCT03754127 . Registered on 22 November 2018.

Indexed as

Transcranial Direct Current StimulationBelgiumChronic DiseaseDouble-Blind MethodFemaleHumansMaleQuality of LifeRandomized Controlled Trials as TopicTime FactorsTinnitusTreatment OutcomeChronic tinnitusNeuromodulationRandomized controlled trialTranscranial direct current stimulation

Identifiers

PMID31370873
PMCPMC6676604
OpenAlexW2966058438

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.