Tinnitus Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
University of Nottingham
RECRUITING
Nottingham
Contact Information
Primary
Magdalena Sereda, PhD
magdalena.sereda@nottingham.ac.uk
00441158232625
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Placebo_comparator: Sham
Same as intervention arm but the current will be delivered at 2mA for 30 seconds, after which the stimulation will be discontinued.
Related Therapeutic Areas
Sponsors
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov