Transcranial Electrical and Acoustic Stimulation for Tinnitus
NCT ID: NCT04551404
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2021-03-24
2025-05-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A pilot study conducted by Shekhawat and colleagues in 2015 tested the effects of simultaneous electrical and acoustic stimulation. Using tDCS and bilateral broadband noise simultaneously, they found that more tinnitus patients report an improvement in tinnitus perception in comparison to conditions only using tDCS or sham. Further similar approaches very published in recent years, namely a pilot study conducted by Teissmann et al in 2014; study protocols of Rabau et al. in 2015 and Shekhawat et al. in 2015; and an experimental study by Lee et al. in 2017. Results were indicative of a superior efficacy of combined electrical and acoustic approaches, while large-scale controlled studies have not been performed. The need for extension and replication of these approaches is therefore timely.
The aim behind our proposed approach, similar to the bimodal approaches above, is to couple the effects of tRNS and acoustic stimulation (AS) for better temporary tinnitus suppression and possible reversal of maladaptive neuroplasticity related to tinnitus. We aim at targeting the (bilateral) auditory cortex with tRNS as in former studies and combine it with white noise (WN) stimulation. This specific combination is novel in its nature and is building on cortical excitability following tRNS.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
NCT02648542
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
NCT01575496
MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus
NCT03544359
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
NCT02285803
Home-based Transcranial Electrical Stimulation (TES) in Patients With Chronic Tinnitus
NCT05189587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
Prior to conducting the above study, a pilot study of 40 patients and just 6 visits will be conducted to validate clinical procedures and outcomes. This procedure was approved by the ethics committee.
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Intervention(s) A
TRNS bilateral temporal regions combined with AS for 20 minutes
Sham-tRNS bilateral temporal regions combined with Sham-AS for 20 minutes
transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions, parallel to the application of AS with WN 15 dB above the individual MML in one study arm. TRNS will be applied using two electrodes (35 qcm, 0,9% saline -soaked). Stimulus intensity will be below individual sensation threshold, but max. 2 mA. AS will never surpass 85 dB SPL at the ears.
Study Intervention(s) B = Control Intervention
TRNS bilateral temporal regions for 20 minutes
Sham-tRNS bilateral temporal regions for 20 minutes
transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions, parallel to the application of AS with WN 15 dB above the individual MML in one study arm. TRNS will be applied using two electrodes (35 qcm, 0,9% saline -soaked). Stimulus intensity will be below individual sensation threshold, but max. 2 mA. AS will never surpass 85 dB SPL at the ears.
transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Persistent chronic tinnitus with duration of more than 3 months
* Signed Informed Consent after being informed about the study
* Fluent in German or English
* Tinnitus with a THI Grade 2 to 4 (18-76 points)
* Willing and able to attend the study visits
Exclusion Criteria
* Hyperacusis
* Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics)
* Implanted pacemaker
* Surgical implants in the head region, such as cochlea implants
* Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss \> 40dB in any measured frequency up to 2kHz
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Known or suspected non-compliance, drug or alcohol abuse
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Zurich, University Zurich
Zurich, Canton of Zurich, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3.
Claes L, Stamberger H, Van de Heyning P, De Ridder D, Vanneste S. Auditory cortex tACS and tRNS for tinnitus: single versus multiple sessions. Neural Plast. 2014;2014:436713. doi: 10.1155/2014/436713. Epub 2014 Dec 22.
Joos K, De Ridder D, Vanneste S. The differential effect of low- versus high-frequency random noise stimulation in the treatment of tinnitus. Exp Brain Res. 2015 May;233(5):1433-40. doi: 10.1007/s00221-015-4217-9. Epub 2015 Feb 19.
Kreuzer PM, Poeppl TB, Rupprecht R, Vielsmeier V, Lehner A, Langguth B, Schecklmann M. Daily high-frequency transcranial random noise stimulation of bilateral temporal cortex in chronic tinnitus - a pilot study. Sci Rep. 2019 Aug 22;9(1):12274. doi: 10.1038/s41598-019-48686-0.
Lee HY, Choi MS, Chang DS, Cho CS. Combined Bifrontal Transcranial Direct Current Stimulation and Tailor-Made Notched Music Training in Chronic Tinnitus. J Audiol Otol. 2017 Apr;21(1):22-27. doi: 10.7874/jao.2017.21.1.22. Epub 2017 Mar 30.
Mohsen S, Mahmoudian S, Talebian S, Pourbakht A. Prefrontal and auditory tRNS in sequence for treating chronic tinnitus: a modified multisite protocol. Brain Stimul. 2018 Sep-Oct;11(5):1177-1179. doi: 10.1016/j.brs.2018.04.018. Epub 2018 Apr 25. No abstract available.
Rabau S, Van Rompaey V, Van de Heyning P. The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial. Trials. 2015 Nov 10;16:514. doi: 10.1186/s13063-015-1041-2.
Shekhawat GS, Kobayashi K, Searchfield GD. Methodology for studying the transient effects of transcranial direct current stimulation combined with auditory residual inhibition on tinnitus. J Neurosci Methods. 2015 Jan 15;239:28-33. doi: 10.1016/j.jneumeth.2014.09.025. Epub 2014 Oct 5.
Teismann H, Wollbrink A, Okamoto H, Schlaug G, Rudack C, Pantev C. Combining transcranial direct current stimulation and tailor-made notched music training to decrease tinnitus-related distress--a pilot study. PLoS One. 2014 Feb 25;9(2):e89904. doi: 10.1371/journal.pone.0089904. eCollection 2014.
Van Doren J, Langguth B, Schecklmann M. Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. Brain Stimul. 2014 Nov-Dec;7(6):807-12. doi: 10.1016/j.brs.2014.08.007. Epub 2014 Aug 26.
Vanneste S, Fregni F, De Ridder D. Head-to-Head Comparison of Transcranial Random Noise Stimulation, Transcranial AC Stimulation, and Transcranial DC Stimulation for Tinnitus. Front Psychiatry. 2013 Dec 18;4:158. doi: 10.3389/fpsyt.2013.00158. eCollection 2013.
Martins ML, Kleinjung T, Meyer M, Raveenthiran V, Wellauer Z, Peter N, Neff P. Transcranial electric and acoustic stimulation for tinnitus: study protocol for a randomized double-blind controlled trial assessing the influence of combined transcranial random noise and acoustic stimulation on tinnitus loudness and distress. Trials. 2022 May 19;23(1):418. doi: 10.1186/s13063-022-06253-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
tEAS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.