Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

Not Applicable

Withdrawn

• Conditions: Tinnitus
• Interventions: Device: noise sound stimulation (Tucker-Davis Technologies); Device: body electrical stimulation (Digitimer device); Device: transcranial magnetic stimulation (Magstim)

• Registration Number: NCT02283216
• Lead Sponsor: University of Minnesota

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 Timeline

• Study First Submitted: 2014-10-26
• Study First Submitted QC: 2014-11-02
• Study First Posted: 2014-11-05
• Study Start: 2015-06-01
• Primary Completion: 2017-09-13
• Study Completion: 2017-09-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acoustic, Body, Cortical	body electrical stimulation (Digitimer device)	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.
Acoustic, Body, Cortical	transcranial magnetic stimulation (Magstim)	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.
Acoustic, Body, Cortical	noise sound stimulation (Tucker-Davis Technologies)	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.

Primary Outcome Measures

Name	Time	Method
Change in Minimal Masking Level	Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm	A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Change in Tinnitus Functional Index Questionnaire Score	Change from baseline score at 1 week after testing paradigm	A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.

Secondary Outcome Measures

Name	Time	Method
Daily Tinnitus Journal Entries	0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm	The subject describes the quality, characteristics and bothering nature of the tinnitus on a daily basis. The subject can also include any unusual or interesting events relating to the tinnitus that he/she feels would be relevant for the study.
Change in Tinnitus Handicap Inventory Questionnaire Score	Change from baseline score at 1 week after testing paradigm	A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Change in Tinnitus Subjective Description	Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm	The subject describes the quality, characteristics and bothering nature of the tinnitus.
Change in Tinnitus Rating (0-10, 10 being worst)	Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm	The subject rates the disturbance or bothering nature of the tinnitus.
Change in Tinnitus Matching (pitch and loudness)	Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm	The subject adjusts the loudness and pitch (i.e., frequency) of a sound played to an ear to that of the tinnitus percept.

Trial Locations

Locations (1)

Nils Hasselmo Hall, 6-105; 🇺🇸 Minneapolis, Minnesota, United States