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

February 9, 2026 updated by: Magdalena Sereda, University of Nottingham

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Direct Current Stimulation (tDCS)
TDCS will be delivered using a NeuroConn DC Stimulator Plus via two 35cm2 rubber electrodes covered in saline-soaked sponges. The anode electrode will be positioned over EEG 10-20 coordinate F4 and the cathode over F3. The current will be delivered at 2mA for 20 minutes with ramp-up and ramp-down of 10 seconds. Each participant will receive 10 daily stimulation sessions over 2 weeks.
Device: transcranial Direct Current Stimulation
transcranial Direct Current Stimulation
Placebo Comparator: Sham
Same as intervention arm but the current will be delivered at 2mA for 30 seconds, after which the stimulation will be discontinued.
Device: transcranial Direct Current Stimulation
transcranial Direct Current Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proof of concept
Time Frame: Assessed at study end (anticipated as 1 year after study start)
Measured by protocol compliance and attrition
Assessed at study end (anticipated as 1 year after study start)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before first intervention session, after final intervention session and at 3-month follow-up
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
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)
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
Before first intervention session, after final intervention session and at 3-month follow-up
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
Before first intervention session, after final intervention session and at 3-month follow-up
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
After final intervention session and at 3-month follow-up
Adverse effects
Time Frame: After each intervention session (10 sessions over 2 weeks)
Measured by in-house adverse effects questionnaire without numerical scoring system.
After each intervention session (10 sessions over 2 weeks)
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.
Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..

Collaborators and Investigators

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

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Magdalena Sereda, PhD, University of Nottingham

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)

December 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 194-0524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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