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

University of Nottingham

Status: Not yet enrolling

Conditions: Tinnitus

Treatments: Device: transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06628414

194-0524

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Transcranial Direct Current Stimulation (tDCS)

Experimental group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation

Sham

Placebo Comparator group

Description:

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

Treatment:

Device: transcranial Direct Current Stimulation