TinnitustEASNCT04551404
Transcranial Electrical and Acoustic Stimulation for Tinnitus
A study testing transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS) and transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS) in people with Tinnitus and Tinnitus, Subjective, run by University of Zurich at 1 site in Switzerland.
Trial summary
Transcranial electrical stimulation (tES) is an umbrella term for non-invasive brain stimulation using weak currents. It comprises transcranial direct current stimulation (tDCS), which is the most established and used method applying constant direct current, transcranial alternating current stimulation (tACS) with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus, Tinnitus, Subjective
- What is being tested?
- transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS) and transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Mar 2021to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 years to 75 years of age (younger age limit according to corona virus protection concepts and measures of the FOPH: Schutzkonzepte und -massnahmen (admin.ch))
- 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
Who cannot join
- Actual neurological or psychiatric disorders
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, University Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial
Transcranial electrical stimulation (tES) is an umbrella term for non-invasive brain stimulation using weak currents. It comprises transcranial direct current stimulation (tDCS), which is the most established and used method applying constant direct current, transcranial alternating current stimulation (tACS) with sinusoidal current in a fixed frequency, and finally transcranial random noise stimulation (tRNS), which is a subform of tACS generating a random range of low and high frequency alternating currents.
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.
- Conditions
- Tinnitus, Tinnitus, Subjective
- Being tested
- transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS), transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)Other
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)Other
The study intervention consists of a bilateral tRNS application over temporal regions
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention(s) A | Experimental | TRNS bilateral temporal regions combined with AS for 20 minutes
Sham-tRNS bilateral temporal regions combined with Sham-AS for 20 minutes Receives: Other: transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS) |
| Study Intervention(s) B = Control Intervention | Experimental | TRNS bilateral temporal regions for 20 minutes
Sham-tRNS bilateral temporal regions for 20 minutes Receives: Other: transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of self-report Visual Analogue Scale (VAS) ratings on tinnitus severity (loudness, distress)
Minmum value = 1, maximum value =10. The higher scores means a worse outcome.
Measured: up to 6 months
Change of minimum masking level (MML)
Measured: up to 6 months
Secondary outcomes (1)
event-related EEG power in alpha band
The influence of simultaneous tRNS and AS stimulation on neurophysiology will be investigated as a secondary outcome. Resting state and event-related EEG (auditory oddball) (Attias et al., 1993) will be recorded for that purpose.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start24 Mar 2021
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The crossover within-person design with 2 groups, 2 active conditions and appropriate control/pseudo-placebo/sham session is double-blinded. Overall, participants will undergo 20 stimulation visits and 6 additional assessment visits. 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551404
- Sponsor's protocol ID
- tEAS
- Acronym
- tEAS
- Status last verified
- Feb 2026
- First submitted
- 9 Aug 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27242932Claes 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.
PubMed 25587455Joos 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.
PubMed 25694243Kreuzer 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.
PubMed 31439873Lee 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.
PubMed 28417104Mohsen 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.
PubMed 29730252Rabau 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.
PubMed 26554670Shekhawat 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.
PubMed 25285987Teismann 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.
PubMed 24587113Van 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.
PubMed 25245591Vanneste 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.
PubMed 24391599Martins 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.
PubMed 35590399
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04551404
- Acronym / sponsor ID
- tEAS / tEAS
- Conditions
- Tinnitus, Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial electrical stimulation (tES) is an umbrella term for non-invasive brain stimulation using weak currents. It comprises transcranial direct current stimulation (tDCS), which is the most established and used method applying constant direct current, transcranial alternating current stimulation (tACS) with sinusoidal current in a fixed frequency, and finally transcranial random noise stimulation (tRNS), which is a subform of tACS generating a random range of low and high frequency alternating currents.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The crossover within-person design with 2 groups, 2 active conditions and appropriate control/pseudo-placebo/sham session is double-blinded. Overall, participants will undergo 20 stimulation visits and 6 additional assessment visits. 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.
| Arm | Type | Receives |
|---|---|---|
| Study Intervention(s) A | Experimental | Other: transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)TRNS bilateral temporal regions combined with AS for 20 minutes Sham-tRNS bilateral temporal regions combined with Sham-AS for 20 minutes |
| Study Intervention(s) B = Control Intervention | Experimental | Other: transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)TRNS bilateral temporal regions for 20 minutes Sham-tRNS bilateral temporal regions for 20 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 18 years to 75 years of age (younger age limit according to corona virus protection concepts and measures of the FOPH: Schutzkonzepte und -massnahmen (admin.ch))
- 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)
Key exclusion criteria (11 listed)
- Actual neurological or psychiatric disorders
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Study Intervention(s) A |
| transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)The study intervention consists of a bilateral tRNS application over temporal regions | Other | Study Intervention(s) B = Control Intervention |
Primary outcome
Change of self-report Visual Analogue Scale (VAS) ratings on tinnitus severity (loudness, distress)
Time frame: up to 6 months
Minmum value = 1, maximum value =10. The higher scores means a worse outcome.
Change of minimum masking level (MML)
Time frame: up to 6 months
1 secondary outcome
event-related EEG power in alpha band
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 27242932Antal 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.
- Background: PubMed 25587455Claes 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.
- Background: PubMed 25694243Joos 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.
- Background: PubMed 31439873Kreuzer 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.
- Background: PubMed 28417104Lee 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.
- Background: PubMed 29730252Mohsen 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.
- Background: PubMed 26554670Rabau 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.
- Background: PubMed 25285987Shekhawat 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.
- Background: PubMed 24587113Teismann 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.
- Background: PubMed 25245591Van 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.
- Background: PubMed 24391599Vanneste 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.
- Derived from this study: PubMed 35590399Martins 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS) and transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS) in people with Tinnitus and Tinnitus, Subjective, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of self-report Visual Analogue Scale (VAS) ratings on tinnitus severity (loudness, distress) (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551404, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.