MedPath

Auditory Plasticity Training

Not Applicable
Recruiting
Conditions
Mild Traumatic Brain Injury
Interventions
Other: Speech in Noise Training
Other: Spatial Hearing Training Group
Other: Spatial Hearing Control Group
Registration Number
NCT06628505
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Brief Summary

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.

Detailed Description

The study has two aims:

1. 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.

2. 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Age 18-55 years
  • English is the primary language
  • History of mTBI by self report
Exclusion Criteria
  • Pure tone threshold (mean of 0.5-4.0 kHz) > 40dB HL
  • Major neurological or psychiatric conditions besides mTBI

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Speech in Noise Training (SPiN)Speech in Noise TrainingYoung to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group
Spatial Hearing TrainingSpatial Hearing Training GroupYoung to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group
Spatial Hearing Training Control Group Treatment as Usual (TAU)Spatial Hearing Control GroupYoung 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
Primary Outcome Measures
NameTimeMethod
Change in Composite Hearing in Noise ScoreBaseline 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 StimulusBaseline 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 frequencyTime 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.

Change in Spatial Hearing: Sound localization PrecisionBaseline 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.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.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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

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