Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Minimal Masking Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: noise sound stimulation (Tucker-Davis Technologies) (Device)
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.
干预措施: body electrical stimulation (Digitimer device) (Device)
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.
干预措施: transcranial magnetic stimulation (Magstim) (Device)
结局指标
主要结局
Change in Minimal Masking Level
时间窗: 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 Tinnitus Functional Index Questionnaire Score
时间窗: 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.
次要结局
- Daily Tinnitus Journal Entries(0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm)
- Change in Tinnitus Handicap Inventory Questionnaire Score(Change from baseline score at 1 week after testing paradigm)
- Change in Tinnitus Subjective Description(Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm)
- Change in Tinnitus Rating (0-10, 10 being worst)(Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm)
- Change in Tinnitus Matching (pitch and loudness)(Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm)