Transcranial Direct Current Stimulation (tDCS) for Tinnitus - Effects of Multiple Treatment Sessions: a Randomised-controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- transcranial Direct Current Stimulation
- Conditions
- Tinnitus
- Sponsor
- University of Nottingham
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Proof of concept
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Magdalena Sereda
Assistant Professor
University of Nottingham
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
Arms & Interventions
Transcranial Direct Current Stimulation (tDCS)
TDCS will be delivered using a NeuroConn DC Stimulator Plus via two 35cm2 rubber electrodes covered in saline-soaked sponges. The anode electrode will be positioned over EEG 10-20 coordinate F4 and the cathode over F3. The current will be delivered at 2mA for 20 minutes with ramp-up and ramp-down of 10 seconds. Each participant will receive 10 daily stimulation sessions over 2 weeks.
Intervention: transcranial Direct Current Stimulation
Sham
Same as intervention arm but the current will be delivered at 2mA for 30 seconds, after which the stimulation will be discontinued.
Intervention: transcranial Direct Current Stimulation
Outcomes
Primary Outcomes
Proof of concept
Time Frame: Assessed at study end (anticipated as 1 year after study start)
Measured by protocol compliance and attrition
Secondary Outcomes
- Tinnitus symptom severity(Before first intervention session, after final intervention session and at 3-month follow-up)
- 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))
- Depression(Before first intervention session, after final intervention session and at 3-month follow-up)
- Anxiety(Before first intervention session, after final intervention session and at 3-month follow-up)
- Treatment satisfaction(After final intervention session and at 3-month follow-up)
- Adverse effects(After each intervention session (10 sessions over 2 weeks))
- Electrophysiological brain activity(Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..)