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Recruiting NCT06628414

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

No phase Interventional Tinnitus

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcranial Direct Current Stimulation.
Who it may be relevant to
Registry conditions: Tinnitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Transcranial Direct Current Stimulation (tDCS) for Tinnitus - Effects of Multiple Treatment Sessions: a Randomised-controlled Pilot Study

Overview

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.

Interventions

  • Device transcranial Direct Current Stimulation
    transcranial Direct Current Stimulation

Primary outcome measures

  • Proof of concept [Time frame: Assessed at study end (anticipated as 1 year after study start)]
Secondary outcome measures (7)
  • Tinnitus symptom severity [Time frame: Before first intervention session, after final intervention session and at 3-month follow-up]
  • Tinnitus loudness [Time frame: 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 [Time frame: Before first intervention session, after final intervention session and at 3-month follow-up]
  • Anxiety [Time frame: Before first intervention session, after final intervention session and at 3-month follow-up]
  • Treatment satisfaction [Time frame: After final intervention session and at 3-month follow-up]
  • Adverse effects [Time frame: After each intervention session (10 sessions over 2 weeks)]
  • Electrophysiological brain activity [Time frame: Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • University of Nottingham — Nottingham

Identifiers

NCT: NCT06628414 · 194-0524

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗