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

NCT ID: NCT06628414

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, parallel, randomised, sham-controlled pilot trial
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Statistician

Study Groups

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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.

Group Type EXPERIMENTAL

transcranial Direct Current Stimulation

Intervention Type DEVICE

transcranial Direct Current Stimulation

Sham

Same as intervention arm but the current will be delivered at 2mA for 30 seconds, after which the stimulation will be discontinued.

Group Type PLACEBO_COMPARATOR

transcranial Direct Current Stimulation

Intervention Type DEVICE

transcranial Direct Current Stimulation

Interventions

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transcranial Direct Current Stimulation

transcranial Direct Current Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Sereda

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena Sereda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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University of Nottingham

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Magdalena Sereda, PhD

Role: CONTACT

00441158232625

Facility Contacts

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Magdalena Sereda, PhD

Role: primary

0115 7486925

Other Identifiers

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194-0524

Identifier Type: -

Identifier Source: org_study_id

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