Clinical trial NCT06628505: Auditory Plasticity Training
Official title: Targeted Auditory Plasticity Training to Improve Central Hearing in Mild Traumatic Brain Injury (mTBI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Auditory plasticity
Hearing training
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial which will randomize subjects into one of two aims. Each aim will have a 1:1 randomization of participants into either the investigational or the control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Composite Hearing in Noise Score
timeFrame: Baseline to 1 month + 10 days
measure: Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus
timeFrame: Baseline to 1 month + 10days
measure: Change in Frequency Following Response : Amplitude of stimulus fundamental frequency
timeFrame: Time Frame: Baseline to 1 month + 10days
measure: Change in Spatial Hearing: Sound localization Precision
timeFrame: Baseline to 1 month + 4 days
measure: Change in Spatial Hearing: percent of front/back confusions.
timeFrame: Baseline to 1 month + 4 days
measure: Change in P300 amplitude.
timeFrame: Baseline to 1 month + 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Rocio Norman, PhD
role: PRINCIPAL_INVESTIGATOR
References: