Targeted Auditory Plasticity Training to Improve Central Hearing in Mild Traumatic Brain Injury (mTBI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Spatial Hearing: Sound localization Precision
研究概览
简要总结
The investigators are working on a project to help people who have had mild brain injuries hear better. Sometimes, these injuries can make it hard for people to hear clearly, especially in noisy places or when trying to tell where sounds are coming from.
The project is testing special training exercises that have helped healthy people improve their hearing in these situations. The goal is to see if these exercises can also help people with mild traumatic brain injuries (mTBI).
If these exercises work, they could help doctors give better treatment to people with hearing problems after a brain injury. This would be especially helpful for soldiers who need to stay ready for duty. It could also make life better for veterans who struggle with hearing issues and help lower the cost of healthcare.
详细描述
The study has two aims:
- Aim 1 - Speech in noise (SPiN) training: The training group will receive the SPiN training, while the active control group will play a variation of the main Listen game (frequency discrimination) that is not expected to improve speech recognition in noise. Participants will receive a tablet and earphones. The instructions will be explained, and they will practice and work with the experimenter to verify they understand how to run the training at home. Participants will do SPiN and Active Control training at home over 8 days, with up to two, 10 min sessions each day, for a total of 15 training sessions.
- Aim 2 - Spacial hearing training: Two groups will be tested: training and control, and participants will be randomly assigned to one of two groups. The training group will receive Spatial Hearing training, which will be compared to no-contract controls. The study team will avoid withholding training from the controls by considering them a waitlist control group, which will then be offered the training after completing the study as a control participant.The training group does the same spatial hearing task on two days, but on every trial they are given feedback about how the location they thought the sound came from differed from the actual sound location.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •English is the primary language
- •History of mTBI by self report
排除标准
- •Pure tone threshold (mean of 0.5-4.0 kHz) > 40dB HL
- •Major neurological or psychiatric conditions besides mTBI
研究组 & 干预措施
Speech in Noise Training (SPiN)
Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group
干预措施: Speech in Noise Training (Other)
SPiN Control Group Treatment as Usual (TAU)
Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to a treatment as usual group
Spatial Hearing Training
Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group
干预措施: Spatial Hearing Training Group (Other)
Spatial Hearing Training Control Group Treatment as Usual (TAU)
Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to a treatment as usual group
干预措施: Spatial Hearing Control Group (Other)
结局指标
主要结局
Change in Spatial Hearing: Sound localization Precision
时间窗: Baseline to 1 month + 4 days
Sound localization precision will be measured as the absolute difference (in degrees) between the locations of the pointer and the sound target location in the horizontal plane. Smaller values indicate better spatial hearing precision.
Change in Spatial Hearing: percent of front/back confusions.
时间窗: Baseline to 1 month + 4 days
Localization errors \> 45° that cross the interaural axis will be categorized as front/back confusions. The percentage of Front/back confusions among all trials will be measured, and larger percentages indicate worse spatial hearing.
Change in P300 amplitude.
时间窗: Baseline to 1 month + 4 days
Amplitude of the P300 event-related potential in response to target sounds will be measured (in microvolts). Larger amplitudes indicate better spatial attention processing.
Change in Composite Hearing in Noise Score
时间窗: Baseline to 1 month + 10 days
The composite score will be the averaging (equal weighting) of z-scores from two tests: Spatial Release from Masking and Digits in Noise. Each test uses measures of decibels (dB), where smaller dB values indicate better performance.
Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus
时间窗: Baseline to 1 month + 10days
The time point of maximum correlation between the FFR and stimulus waveforms will be calculated. Larger correlation values indicate a more precise neural representation of the stimulus. A Fisher r-to-z transformation will be used to normalize the distribution of correlation values.
Change in Frequency Following Response : Amplitude of stimulus fundamental frequency
时间窗: Time Frame: Baseline to 1 month + 10days
The amplitude of the fundamental frequency will be defined using fast Fourier-transforms, and measured in microvolts. Larger values indicate greater amplitudes.
次要结局
未报告次要终点