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Completed

NCT Number: NCT04551404

Transcranial Electrical and Acoustic Stimulation for Tinnitus

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus, Subjective

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, University Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. Change of minimum masking level (MML)

    Time frame: up to 6 months

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial

Acronym: tEAS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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