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RecruitingNCT06628414WHITBYUpdated Feb 12, 2026

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

An interventional study of transcranial Direct Current Stimulation in Tinnitus, sponsored by University of Nottingham. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by University of Nottingham · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tinnitus

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Keywords

  • tinnitus
  • brain stimulation
  • neuromodulation
  • transcranial direct current stimulation
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Aged under 18
  • Not suffering from tinnitus or suffering from objective tinnitus
  • Insufficient understanding of English to be able to provide
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Devicetranscranial Direct Current Stimulation

    transcranial Direct Current Stimulation

06

What researchers measure

Primary outcomes

  1. Proof of concept

    Measured by protocol compliance and attrition

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

Secondary outcomes

  1. Tinnitus symptom severity

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

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

  2. Tinnitus loudness

    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

    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)

  3. Depression

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

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

  4. Anxiety

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

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

  5. Treatment satisfaction

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

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

  6. Adverse effects

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

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

  7. Electrophysiological brain activity

    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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06628414
Responsible party
Magdalena Sereda (Assistant Professor, University of Nottingham) — Principal investigator
First posted
Oct 8, 2024
Start date
Dec 1, 2024
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Feb 12, 2026

Study contacts

Magdalena Sereda, PhD
Contact
magdalena.sereda@nottingham.ac.uk
00441158232625
Magdalena Sereda, PhD
principal investigator · University of Nottingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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