Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

April 29, 2019 updated by: University of Minnesota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Nils Hasselmo Hall, 6-105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: noise sound stimulation (Tucker-Davis Technologies)
Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tinnitus Functional Index Questionnaire Score
Time Frame: 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 from baseline score at 1 week after testing paradigm
Change in Minimal Masking Level
Time Frame: 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 baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tinnitus Handicap Inventory Questionnaire Score
Time Frame: 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 from baseline score at 1 week after testing paradigm
Change in Tinnitus Rating (0-10, 10 being worst)
Time Frame: 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 baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Subjective Description
Time Frame: 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 baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Matching (pitch and loudness)
Time Frame: 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.
Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm
Daily Tinnitus Journal Entries
Time Frame: 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.
0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Hubert Lim, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 13, 2017

Study Completion (Actual)

September 13, 2017

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

November 2, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1409M53708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe