Auditory Plasticity Training

The University of Texas System (UT)

Status: Enrolling

Conditions: Mild Traumatic Brain Injury

Treatments: Other: Spatial Hearing Control Group; Other: Speech in Noise Training; Other: Spatial Hearing Training Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06628505

TP230338P1 (Other Grant/Funding Number)

STUDY00000423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Speech in Noise Training (SPiN)

Active Comparator group

Description:

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

Treatment:

Other: Speech in Noise Training

SPiN Control Group Treatment as Usual (TAU)

No Intervention group

Description:

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

Active Comparator group

Description:

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

Treatment:

Other: Spatial Hearing Training Group

Spatial Hearing Training Control Group Treatment as Usual (TAU)

Other group

Description:

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

Treatment:

Other: Spatial Hearing Control Group