Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

Withdrawn before enrolling · Not applicable

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT02283216

Run by

University of Minnesota

People needed

0

Starts

2015-06-01

Expected to finish

2017-09-13

Last updated by the study team

2019-05-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have subjective, non-pulsatile, and bothersome tinnitus
• Will not start any new tinnitus treatment during the study
• Ability to give informed consent and understand study objectives in English
• Willing and able to understand and comply with all study-related procedures

You may not qualify if…

• Substantial hearing loss or hyperacusis that may interfere with the study
• Medical history of other ear or brain disorders, history of seizures, or currently using any medication or treatments that can cause or increase the chances of seizures
• Any implanted medical or metal device, such as a pacemaker, aneurysm clip, or cochlear implant
• Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children need extra protection for their safety)
• Any handicap that prevents the subject from reliably performing the tests

Where it is running

• Nils Hasselmo Hall, 6-105 — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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