Auditory Plasticity Training

Официальное название

Targeted Auditory Plasticity Training to Improve Central Hearing in Mild Traumatic Brain Injury (mTBI)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Speech in Noise Training
  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.
• Другое Spatial Hearing 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 ah
• Другое Spatial Hearing Control 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 ah

Первичные конечные точки

• Change in Composite Hearing in Noise Score [Срок оценки: Baseline to 1 month + 10 days]
• Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus [Срок оценки: Baseline to 1 month + 10days]
• Change in Frequency Following Response : Amplitude of stimulus fundamental frequency [Срок оценки: Time Frame: Baseline to 1 month + 10days]
• Change in Spatial Hearing: Sound localization Precision [Срок оценки: Baseline to 1 month + 4 days]
• Change in Spatial Hearing: percent of front/back confusions. [Срок оценки: Baseline to 1 month + 4 days]
• Change in P300 amplitude. [Срок оценки: Baseline to 1 month + 4 days]

Критерии участия

Критерии включения

• Age 18-55 years
• English is the primary language
• History of mTBI by self report

Критерии исключения

• Pure tone threshold (mean of 0.5-4.0 kHz) > 40dB HL
• Major neurological or psychiatric conditions besides mTBI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at San Antonio — San Antonio

Идентификаторы

NCT: NCT06628505 · STUDY00000423 · TP230338P1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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