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Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

Primary Purpose

Tinnitus

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
noise sound stimulation (Tucker-Davis Technologies)
body electrical stimulation (Digitimer device)
transcranial magnetic stimulation (Magstim)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Tinnitus focused on measuring neuromodulation, noninvasive, plasticity, transcranial magnetic stimulation, hearing, hyperacusis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nils Hasselmo Hall, 6-105

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acoustic, Body, Cortical

Arm 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.

Outcomes

Primary Outcome Measures

Change in Tinnitus Functional Index Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Change in Minimal Masking Level
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.

Secondary Outcome Measures

Change in Tinnitus Handicap Inventory Questionnaire Score
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 Rating (0-10, 10 being worst)
The subject rates the disturbance or bothering nature of the tinnitus.
Change in Tinnitus Subjective Description
The subject describes the quality, characteristics and bothering nature of the tinnitus.
Change in Tinnitus Matching (pitch and loudness)
The subject adjusts the loudness and pitch (i.e., frequency) of a sound played to an ear to that of the tinnitus percept.
Daily Tinnitus Journal Entries
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.

Full Information

First Posted
October 26, 2014
Last Updated
April 29, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02283216
Brief Title
Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
Official Title
Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding and personnel
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
September 13, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
neuromodulation, noninvasive, plasticity, transcranial magnetic stimulation, hearing, hyperacusis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acoustic, Body, Cortical
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
noise sound stimulation (Tucker-Davis Technologies)
Intervention Description
Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.
Intervention Type
Device
Intervention Name(s)
body electrical stimulation (Digitimer device)
Intervention Description
Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device.
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation (Magstim)
Intervention Description
Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device.
Primary Outcome Measure Information:
Title
Change in Tinnitus Functional Index Questionnaire Score
Description
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Time Frame
Change from baseline score at 1 week after testing paradigm
Title
Change in Minimal Masking Level
Description
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.
Time Frame
Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm
Secondary Outcome Measure Information:
Title
Change in Tinnitus Handicap Inventory Questionnaire Score
Description
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Time Frame
Change from baseline score at 1 week after testing paradigm
Title
Change in Tinnitus Rating (0-10, 10 being worst)
Description
The subject rates the disturbance or bothering nature of the tinnitus.
Time Frame
Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Title
Change in Tinnitus Subjective Description
Description
The subject describes the quality, characteristics and bothering nature of the tinnitus.
Time Frame
Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Title
Change in Tinnitus Matching (pitch and loudness)
Description
The subject adjusts the loudness and pitch (i.e., frequency) of a sound played to an ear to that of the tinnitus percept.
Time Frame
Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm
Title
Daily Tinnitus Journal Entries
Description
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.
Time Frame
0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Lim, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nils Hasselmo Hall, 6-105
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

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