Clinical trial NCT06628414: WHITBY: Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation StudY
Official title: Transcranial Direct Current Stimulation (tDCS) for Tinnitus - Effects of Multiple Treatment Sessions: a Randomised-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
brain stimulation
neuromodulation
transcranial direct current stimulation
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, parallel, randomised, sham-controlled pilot trial
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proof of concept
timeFrame: Assessed at study end (anticipated as 1 year after study start)
Secondary outcomes:
measure: Tinnitus symptom severity
timeFrame: Before first intervention session, after final intervention session and at 3-month follow-up
measure: Tinnitus loudness
timeFrame: 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)
measure: Depression
timeFrame: Before first intervention session, after final intervention session and at 3-month follow-up
measure: Anxiety
timeFrame: Before first intervention session, after final intervention session and at 3-month follow-up
measure: Treatment satisfaction
timeFrame: After final intervention session and at 3-month follow-up
measure: Adverse effects
timeFrame: After each intervention session (10 sessions over 2 weeks)
measure: Electrophysiological brain activity
timeFrame: Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham
name: Magdalena Sereda, PhD
role: PRINCIPAL_INVESTIGATOR
References: