Clinical trial NCT02283216: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Tinnitus
Keywords: neuromodulation
noninvasive
plasticity
transcranial magnetic stimulation
hearing
hyperacusis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Change in Tinnitus Functional Index Questionnaire Score
timeFrame: Change from baseline score at 1 week after testing paradigm
measure: Change in Minimal Masking Level
timeFrame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm
Secondary outcomes:
measure: Change in Tinnitus Handicap Inventory Questionnaire Score
timeFrame: Change from baseline score at 1 week after testing paradigm
measure: Change in Tinnitus Rating (0-10, 10 being worst)
timeFrame: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
measure: Change in Tinnitus Subjective Description
timeFrame: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
measure: Change in Tinnitus Matching (pitch and loudness)
timeFrame: Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm
measure: Daily Tinnitus Journal Entries
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Nils Hasselmo Hall, 6-105
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Hubert Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References: