Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02283216
Status:
WITHDRAWN
Last Update Posted:
2019-05-01
First Post:
2014-10-26
Brief Title:
Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
Status:
WITHDRAWN
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding and personnel
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate different stimulation parameters for a new noninvasive approach for modulating the brain that could potentially be beneficial for decreasing tinnitus perception The new approach is called Multimodal Synchronization Therapy mSync mSync uses a combination of acoustic stimulation played through headphones and low levels of electrical current delivered via electrodes placed on the surface of different body regions The timing interval between the acoustic and body stimulation is varied in order to cause different types of changes in the brain In addition to acoustic and body stimulation noninvasive cortical stimulation will also be presented as part of mSync to attempt to further modulate or decrease the tinnitus percept Cortical stimulation will be performed by placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can travel through the skin and bone to create electrical current inside the head For this study different body locations as well as specific timing intervals among acoustic body and cortical stimulation will be investigated to identify appropriate parameters that can modulate and potentially decrease tinnitus perception Different mSync parameters will be investigated across multiple testing sessions up to 16 weekly sessions and the tinnitus percept will be closely monitored throughout the study
Detailed Description:
This study is not specifically seeking to treat tinnitus but is designed to investigate various mSync parameters that can alter the tinnitus percept Findings from this study will help identify specific mSync parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study
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