Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

University of Minnesota (UMN)

Status: Withdrawn

Conditions: Tinnitus

Treatments: Device: noise sound stimulation (Tucker-Davis Technologies); Device: transcranial magnetic stimulation (Magstim); Device: body electrical stimulation (Digitimer device)

Study type: Interventional

Funder types: Other

Identifiers

NCT02283216

1409M53708

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Acoustic, Body, Cortical

Experimental group

Description:

Acoustic corresponds to noise sound stimulation. Body corresponds to body electrical stimulation. Cortical corresponds to transcranial magnetic stimulation. Acoustic is presented together with body and cortical stimulation. Different body locations and timing among acoustic, body, and cortical stimulation are presented across testing sessions.

Treatment:

Device: transcranial magnetic stimulation (Magstim)

Device: body electrical stimulation (Digitimer device)

Device: noise sound stimulation (Tucker-Davis Technologies)