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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
40
transcranial Direct Current Stimulation
University of Nottingham
Nottingham, United Kingdom
RECRUITINGProof of concept
Measured by protocol compliance and attrition
Time frame: Assessed at study end (anticipated as 1 year after study start)
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-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
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
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-up
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-up
Treatment satisfaction
Measured by Short Assessment of Patient Satisfaction (SAPS) scores can range from 0 to 28 with higher scores indicating greater satisfaction
Time frame: After final intervention session and at 3-month follow-up
Adverse effects
Measured by in-house adverse effects questionnaire without numerical scoring system.
Time frame: 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.
Time frame: Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..
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