Transcranial Electrical and Acoustic Stimulation for Tinnitus (tEAS)

February 3, 2026 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8091
        • University Hospital Zurich, University Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
Experimental: Study Intervention(s) B = Control Intervention

TRNS bilateral temporal regions for 20 minutes

Sham-tRNS bilateral temporal regions for 20 minutes
Other: transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months
Change of minimum masking level (MML)
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
event-related EEG power in alpha band
Time Frame: up to 6 months
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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

May 13, 2025

Study Completion (Actual)

May 13, 2025

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tEAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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