Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

NCT ID: NCT02283216

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2017-09-13

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.

Conditions

Tinnitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Acoustic, Body, Cortical

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.

Group Type: EXPERIMENTAL

noise sound stimulation (Tucker-Davis Technologies)

Intervention Type: DEVICE

Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.

body electrical stimulation (Digitimer device)

Intervention Type: DEVICE

Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device.

transcranial magnetic stimulation (Magstim)

Intervention Type: DEVICE

Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device.

Interventions

noise sound stimulation (Tucker-Davis Technologies)

Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.

Intervention Type: DEVICE

body electrical stimulation (Digitimer device)

Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device.

Intervention Type: DEVICE

transcranial magnetic stimulation (Magstim)

Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert Lim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Nils Hasselmo Hall, 6-105

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1409M53708

Identifier Type: -

Identifier Source: org_study_id