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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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