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

NCT06628414 | Recruiting

• 1 other identifier: 194-0524
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

tinnitus; brain stimulation; neuromodulation; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Proof of concept

  Measured by protocol compliance and attrition

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

Secondary Outcomes (7)

• Tinnitus symptom severity

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

• Tinnitus 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

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

• Anxiety

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

• Treatment satisfaction

  After final intervention session and at 3-month follow-up

Study Arms (2)

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

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

Sham

PLACEBO COMPARATOR

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

transcranial Direct Current Stimulation DEVICE

transcranial Direct Current Stimulation

Sham; Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Magdalena Sereda, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Sereda, PhD

CONTACT

00441158232625; magdalena.sereda@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double-blind, parallel, randomised, sham-controlled pilot trial

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 8, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)