Tinnitus
Conditions
Keywords
tinnitus, brain stimulation, neuromodulation, transcranial direct current stimulation
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.
Interventions
DEVICEtranscranial Direct Current Stimulation
transcranial Direct Current Stimulation
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Statistician
Intervention model description
Double-blind, parallel, randomised, sham-controlled pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proof of concept | Assessed at study end (anticipated as 1 year after study start) | Measured by protocol compliance and attrition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus symptom severity | Before first intervention session, after final intervention session and at 3-month follow-up | Measured by Tinnitus Functional Index (TFI); maximum score: 100, higher score indicates greater tinnitus symptom severity |
| Tinnitus loudness | 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) | 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 |
| Depression | Before first intervention session, after final intervention session and at 3-month follow-up | Measured by Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms |
| Anxiety | Before first intervention session, after final intervention session and at 3-month follow-up | Measured by Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety |
| Treatment satisfaction | After final intervention session and at 3-month follow-up | Measured by Short Assessment of Patient Satisfaction (SAPS) scores can range from 0 to 28 with higher scores indicating greater satisfaction |
| Adverse effects | After each intervention session (10 sessions over 2 weeks) | Measured by in-house adverse effects questionnaire without numerical scoring system. |
| Electrophysiological brain activity | Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks).. | 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. |
Countries
United Kingdom
Contacts
CONTACTMagdalena Sereda, PhD
PRINCIPAL_INVESTIGATORMagdalena Sereda, PhD
University of Nottingham
Outcome results
None listed