Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628414
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
WHITBY Working Towards Better Healthcare Interventions for Tinnitus a Brain Stimulation StudY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcranial Direct Current Stimulation tDCS for Tinnitus - Effects of Multiple Treatment Sessions a Randomised-controlled Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHITBY
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 eg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None