Auditory Plasticity Training
Targeted Auditory Plasticity Training to Improve Central Hearing in Mild Traumatic Brain Injury (mTBI)
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2024
CompletedStudy Start
First participant enrolled
September 15, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
November 21, 2025
November 1, 2025
2.5 years
August 29, 2024
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in Composite Hearing in Noise Score
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.
Baseline to 1 month + 10 days
Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus
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.
Baseline to 1 month + 10days
Change in Frequency Following Response : Amplitude of stimulus fundamental frequency
The amplitude of the fundamental frequency will be defined using fast Fourier-transforms, and measured in microvolts. Larger values indicate greater amplitudes.
Time Frame: Baseline to 1 month + 10days
Change in Spatial Hearing: Sound localization Precision
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.
Baseline to 1 month + 4 days
Change in Spatial Hearing: percent of front/back confusions.
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.
Baseline to 1 month + 4 days
Change in P300 amplitude.
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
Study Arms (4)
Speech in Noise Training (SPiN)
ACTIVE COMPARATORYoung to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group
SPiN Control Group Treatment as Usual (TAU)
NO INTERVENTIONYoung 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
ACTIVE COMPARATORYoung 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)
OTHERYoung 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
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18-55 years
- English is the primary language
- History of mTBI by self report
You may not qualify if:
- Pure tone threshold (mean of 0.5-4.0 kHz) \> 40dB HL
- Major neurological or psychiatric conditions besides mTBI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rocio Norman, PhD
The University of Texas Health Science Center at San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2024
First Posted
October 8, 2024
Study Start
September 15, 2024
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
November 21, 2025
Record last verified: 2025-11