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

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: Tinnitus
• Intervention / Treatment: Device: transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magdalena Sereda, PhD; Phone Number: 00441158232625; Email: magdalena.sereda@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Recruiting
    • University of Nottingham
    • Contact: Magdalena Sereda, PhD; Phone Number: 0115 7486925; Email: Magdalena.Sereda@nottingham.ac.uk

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	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	Measured by in-house adverse effects questionnaire without numerical scoring system.	After each intervention session (10 sessions over 2 weeks)
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.	Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..

Collaborators and Investigators

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

Study record dates

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: transcranial direct current stimulation; neuromodulation; tinnitus; brain stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• 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