Auditory Plasticity Training
Targeted Auditory Plasticity Training to Improve Central Hearing in Mild Traumatic Brain Injury (mTBI)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rocio Norman, PhD
- Phone Number: (210) 450-8352
- Email: normanr@uthscsa.edu
Study Contact Backup
- Name: Alicia Swan, PhD
- Phone Number: (210) 671-5300
- Email: Alicia.swan@va.gov
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- Recruiting
- The University of Texas Health Science Center at San Antonio
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Contact:
- Rocio Norman, PhD
- Phone Number: 210-450-8352
- Email: normanr@uthscsa.edu
-
Contact:
- Alicia Swan, PhD
- Phone Number: 210-671-5300 x14028
- Email: Alicia.swan@va.gov
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
The active controls will receive frequency discrimination training that uses the same visual landscape and basic task of controlling the wisp based on judgments about acoustic cues.
The task requires participants to avoid obstacles by swiping upward or downward on the touchscreen to indicate whether a test frequency associated with the obstacle was higher or lower, respectively, than a target sound presented slightly before the test sound.
Other Names:
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No Intervention: 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
|
|
|
Active Comparator: 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
|
Stimulus presentation and response measurement (Aim 2): Acoustic stimuli will be presented with a 360° speaker array that are fixed in place behind an opaque, nearly sound transparent, acoustic fabric curtain to avoid visual influences. Manual responses will be collected using a keyboard. Custom Matlab scripts control all relevant variables with millisecond precision. A webcam monitors the participant (not recorded) for the sole purpose of making sure the participant is always facing straight ahead. Sound localization task and training: Participants will judge the location of a target white noise sound (1000 ms, 70 dB SLP, 10-10,000 Hz) by moving an auditory pointer that appears 2 seconds after the offset of the target sound. The training group are given feedback about how their perceived location related to the actual sound location. |
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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
|
Stimulus presentation and response measurement (Aim 2): Acoustic stimuli will be presented with a 360° speaker array that are fixed in place behind an opaque, nearly sound transparent, acoustic fabric curtain to avoid visual influences. Manual responses will be collected using a keyboard. Custom Matlab scripts control all relevant variables with millisecond precision. A webcam monitors the participant (not recorded) for the sole purpose of making sure the participant is always facing straight ahead. Sound localization task and training: Participants will judge the location of a target white noise sound (1000 ms, 70 dB SLP, 10-10,000 Hz) by moving an auditory pointer that appears 2 seconds after the offset of the target sound. The training group are NOT given feedback about how their perceived location related to the actual sound location.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Composite Hearing in Noise Score
Time Frame: Baseline to 1 month + 10 days
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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.
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Baseline to 1 month + 10 days
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Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus
Time Frame: Baseline to 1 month + 10days
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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.
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Baseline to 1 month + 10days
|
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Change in Frequency Following Response : Amplitude of stimulus fundamental frequency
Time Frame: Time Frame: Baseline to 1 month + 10days
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The amplitude of the fundamental frequency will be defined using fast Fourier-transforms, and measured in microvolts.
Larger values indicate greater amplitudes.
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Time Frame: Baseline to 1 month + 10days
|
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Change in Spatial Hearing: Sound localization Precision
Time Frame: Baseline to 1 month + 4 days
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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.
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Baseline to 1 month + 4 days
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Change in Spatial Hearing: percent of front/back confusions.
Time Frame: Baseline to 1 month + 4 days
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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.
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Baseline to 1 month + 4 days
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Change in P300 amplitude.
Time Frame: Baseline to 1 month + 4 days
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Amplitude of the P300 event-related potential in response to target sounds will be measured (in microvolts).
Larger amplitudes indicate better spatial attention processing.
|
Baseline to 1 month + 4 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rocio Norman, PhD, The University of Texas Health Science Center at San Antonio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000423
- TP230338P1 (Other Grant/Funding Number: Department of Defense)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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