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NCT Number: NCT06628414

WHITBY: Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation studY

Tinnitus - the awareness of sound without any outside source - affects around 15% of people and can cause anxiety and depression. Treatment options are limited and do not address tinnitus directly (e.g., reduce its loudness). To do that, we must change brain activity causing tinnitus. Low-dose electrical stimulation, using a technique called transcranial Direct Current Stimulation (tDCS), is a promising approach. The technique is safe and easy to administer. Several small studies have tested tDCS for tinnitus showing some benefits.

To assess whether these benefits will generalise to other patients, we need to conduct a randomised controlled trial - a large, rigorously controlled experiment based on prior agreed procedures. Clinical trials are expensive and time-consuming to run and thus require meticulous pilot work to establish the most effective treatment regimens and the most sensitive measures of treatment outcome. The current study aims to provide such pilot information for a clinical trial of tDCS treatment of tinnitus. Using a total of 40 patients, we will establish how to best to administer tDCS and measure resulting changes in tinnitus perception and associated brain activity.

The current study is a crucial first step towards determining whether or not tDCS can effectively treat tinnitus.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, United Kingdom

Location status: Recruiting

Location contact

Magdalena Sereda, PhD

CONTACT

[email protected]

0115 7486925

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 or over
  • Suffering from subjective idiopathic tinnitus
  • Sufficient understanding of English to be able to provide informed consent
  • Able to safely undergo tDCS

Exclusion criteria

  • Aged under 18
  • Not suffering from tinnitus or suffering from objective tinnitus
  • Insufficient understanding of English to be able to provide informed consent
  • Unable to safely undergo tDCS as assessed by tDCS Safety Questionnaire
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Treatment and study plan

Transcranial Direct Current Stimulation

Device

transcranial Direct Current Stimulation

Primary outcomes

  1. Proof of concept

    Time frame: Assessed at study end (anticipated as 1 year after study start)

    Measured by protocol compliance and attrition

Secondary outcomes

  1. Tinnitus symptom severity

    Time frame: Before first intervention session, after final intervention session and at 3-month follow-up

    Measured by Tinnitus Functional Index (TFI); maximum score: 100, higher score indicates greater tinnitus symptom severity

  2. Tinnitus loudness

    Time frame: Before first intervention session, after each intervention session and at 3-month follow-up (VAS). Before first intervention session and after final intervention session (loudness matching)

    Measured by 10-point visual analogue scale, higher score indicates higher tinnitus loudness and by audiometric tinnitus loudness matching, with higher dB indicating higher loudness

  3. Depression

    Time frame: Before first intervention session, after final intervention session and at 3-month follow-up

    Measured by Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms

  4. Anxiety

    Time frame: Before first intervention session, after final intervention session and at 3-month follow-up

    Measured by Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety

  5. Treatment satisfaction

    Time frame: After final intervention session and at 3-month follow-up

    Measured by Short Assessment of Patient Satisfaction (SAPS) scores can range from 0 to 28 with higher scores indicating greater satisfaction

  6. Adverse effects

    Time frame: After each intervention session (10 sessions over 2 weeks)

    Measured by in-house adverse effects questionnaire without numerical scoring system.

  7. Electrophysiological brain activity

    Time frame: Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..

    Spontaneous oscillatory and auditory-evoked brain activity and coherence will be measured using 32-channel EEG. We will acquire basic structural brain images on a subset of 10 representative subjects to test the feasibility of creating individualised head models for EEG source imaging and tDCS current flow modelling.

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Sereda, PhD

CONTACT

[email protected]

00441158232625

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) for Tinnitus - Effects of Multiple Treatment Sessions: a Randomised-controlled Pilot Study

Acronym: WHITBY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Feb 12, 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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