WHITBY: Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation studY
ConditionTinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nottingham
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial Direct Current Stimulation
Devicetranscranial Direct Current Stimulation
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Transcranial Direct Current Stimulation (tDCS)Experimental treatment 1 intervention
Group B: ShamPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proof of concept
Measured by protocol compliance and attrition
Time frame
Assessed at study end (anticipated as 1 year after study start)Secondary outcomes
1
Tinnitus symptom severity
Measured by Tinnitus Functional Index (TFI); maximum score: 100, higher score indicates greater tinnitus symptom severity
Time frame
Before first intervention session, after final intervention session and at 3-month follow-up2
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
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)3
Depression
Measured by Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms
Time frame
Before first intervention session, after final intervention session and at 3-month follow-up4
Anxiety
Measured by Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety
Time frame
Before first intervention session, after final intervention session and at 3-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov