Clinical Trial: Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

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 Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

  • 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 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.


Original Primary Outcome:

  • 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 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, dB SPL) is determined that completely masks the tinnitus percept.


Current Secondary Outcome:

  • 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 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 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 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: October 26, 2014
Date Started: June 2015
Date Completion: May 2018
Last Updated: March 3, 2017
Last Verified: March 2017