Auditory Plasticity Training for Traumatic Brain Injury

Overseen By Rocio Norman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Major neurological, psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with mild traumatic brain injuries (mTBI) who struggle to hear in noisy environments or locate sound sources. Researchers are testing special hearing exercises to determine if they can enhance hearing for those affected by mTBI, similar to their effects on individuals without injuries. The trial includes different groups, with some receiving usual care and others undergoing specific training such as Auditory Plasticity Training (also known as Formal Auditory Training, Auditory Training, or Central Auditory Processing Training), Speech in Noise Training (SPiN), or Spatial Hearing Training. Individuals who have experienced a mild brain injury and have difficulty hearing may find this trial suitable. As an unphased trial, this study provides a unique opportunity to explore innovative hearing exercises that could significantly improve quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these auditory training exercises are safe for people with mild traumatic brain injuries?

Research shows that the training exercises under testing have been well-tolerated by healthy individuals in the past. For the Speech in Noise Training, studies have found that people with mild traumatic brain injury (mTBI) often struggle to understand speech in noisy environments. However, the studies available have noted no specific safety concerns.

Similarly, earlier research suggests that Spatial Hearing Training can improve hearing test results for people with mTBI. These exercises have not been reported to cause major side effects.

Overall, both types of training aim to improve hearing without significant risks. The absence of specific safety issues in previous studies suggests these exercises are generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Auditory Plasticity Training for traumatic brain injury (TBI) because it offers a unique approach to improving hearing impairments that often occur after such injuries. Unlike standard treatments that might focus on hearing aids or medication, this training aims to reshape how the brain processes sound. By engaging the brain's plasticity, it could enhance the ability to understand speech in noisy environments or improve spatial hearing, which are common challenges for TBI patients. This innovative method could lead to better, more personalized rehabilitation strategies for those struggling with hearing issues post-TBI.

What evidence suggests that this trial's treatments could be effective for improving hearing in people with mild traumatic brain injuries?

This trial will compare different auditory training methods for individuals with mild traumatic brain injuries (mTBI). Studies have shown that listening exercises can help people with mTBI improve their hearing. Participants may be assigned to the Speech in Noise Training (SPiN) group, which involves practicing listening to speech in noisy places to enhance focus in such environments over the long term. Alternatively, participants may join the Spatial Hearing Training group, which involves training to understand sound origins, significantly improving how the brain processes sounds. These exercises have shown promise in helping people with mTBI handle challenging listening situations more effectively. Both methods have proven effective in managing hearing challenges after a brain injury. ^{2 6 7 8 9}

Who Is on the Research Team?

Rocio Norman, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced mild traumatic brain injuries or concussions and are facing challenges with hearing, especially in noisy environments or pinpointing the direction of sounds. It aims to help improve their auditory capabilities.

Inclusion Criteria

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

I do not have major neurological or psychiatric conditions besides mild traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo Speech in Noise (SPiN) and Spatial Hearing training at home over 8 days, with up to two, 10 min sessions each day, for a total of 15 training sessions.

2 weeks

Follow-up

Participants are monitored for changes in hearing abilities, including frequency following response and spatial hearing precision.

1 month + 10 days

What Are the Treatments Tested in This Trial?

Interventions

• Auditory Plasticity Training

Trial Overview The study is examining the effectiveness of special auditory training exercises designed to enhance speech understanding in noise and spatial hearing abilities. Participants will be divided into groups to receive different types of hearing training.

How Is the Trial Designed?

Group I: Spatial Hearing Training Control Group Treatment as Usual (TAU) Experimental Treatment 1 Intervention

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

Group II: SPiN Control Group Treatment as Usual (TAU) Active Control 1 Intervention

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

Group III: Speech in Noise Training (SPiN) Active Control 1 Intervention

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

Group IV: Spatial Hearing Training Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Individuals with mild traumatic brain injury showed significant improvements in behavioral tests of central auditory processing six months after completing formal auditory training, indicating the training's effectiveness.

Despite the behavioral improvements, electrophysiological measures (P300 assessments) remained stable over time, suggesting that while training can enhance auditory processing skills, it may not affect the underlying neural responses measured by P300.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild Traumatic Brain Injury: Long-Term Follow-Up of Central Auditory Processing After Auditory Training. Buriti, AKL., Gil, D.[2022]

A review of studies on auditory training for older adults with hearing loss since 2013 found that most studies had low to moderate quality, highlighting issues like lack of blinding, control groups, and small sample sizes.

The effectiveness of auditory training remains uncertain, indicating a need for future high-quality randomized controlled trials to better assess long-term outcomes and various measures of effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Considerations for Auditory Training Interventions for Adults With Hearing Loss: A Rapid Review. Gaeta, L., Stark, RK., Ofili, E.[2021]

Research on the rodent auditory cortex has significantly advanced our understanding of how learning and sensory experiences can induce changes in brain structure and function, particularly during critical and post-critical periods of development.

Recent studies highlight the potential of auditory training as a practical tool to improve auditory processing abilities in both children with developmental impairments and adults with acquired auditory deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifelong plasticity in the rat auditory cortex: basic mechanisms and role of sensory experience. de Villers-Sidani, E., Merzenich, MM.[2019]

A study involving 29 adult cochlear implant users with partial deafness found that while the proposed auditory training was deemed useful for rehabilitation, it was also considered difficult, particularly for identifying mid- and high-frequency sounds.

Women reported significantly more difficulties than men in performing the auditory training exercises, highlighting the need for tailored support in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of the auditory training of the subjects presenting with partial deafness following cochlear implantation as reported by the patients and speech therapists]. Solnitsa, I., Kobosko, I., Pankovska, A., et al.[2014]

A study involving six adults aged 20 to 37 with severe traumatic brain injury showed that acoustically controlled auditory training led to long-term improvements in auditory processing, as evidenced by changes in brainstem response measurements one year after training.

The training resulted in increased amplitudes and improved latencies in auditory brainstem responses, indicating enhanced auditory function, while behavioral assessments remained stable, suggesting lasting benefits from the training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and electrophysiological auditory processing measures in traumatic brain injury after acoustically controlled auditory training: a long-term study. Figueiredo, CC., Andrade, AN., Marangoni-Castan, AT., et al.[2018]

Auditory integration training (AIT) is a promising treatment for auditory disorders, including sound sensitivity and auditory processing issues, although research is still limited.

Preliminary data suggests that AIT may improve word recognition scores in noisy environments for children with various auditory disorders, indicating potential efficacy in enhancing auditory processing abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Integration Training: One Clinician's View. Madell, JR.[2019]

The auditory cortex can undergo significant plastic changes throughout life, adapting to new auditory experiences, such as after cochlear implantation, which can be beneficial for hearing recovery.

However, prolonged exposure to certain acoustic environments can lead to changes similar to those caused by noise trauma, and in children, a lack of auditory stimulation can hinder normal cortical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of sound in adult and developmental auditory cortical plasticity. Eggermont, JJ.[2008]

Patients with mild traumatic brain injury (mTBI) showed lower activation in the auditory cortex during listening tasks compared to normative controls, indicating potential auditory processing deficits.

The study found reduced connectivity between the left and right auditory cortices in mTBI patients, especially those with clinical auditory processing deficits, suggesting that functional MRI can effectively assess auditory function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central auditory processing disorders after mild traumatic brain injury. Santhanam, P., Meehan, A., Orrison, WW., et al.[2019]

Auditory input and experience can lead to significant plasticity in the auditory cortex, with changes that can be rapid or long-term, depending on factors like attention and learning strategies.

While most auditory plasticity is adaptive and can enhance auditory performance, maladaptive changes associated with cochlear trauma and partial hearing loss can lead to conditions like tinnitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasticity in the auditory system. Irvine, DRF.[2019]

The brain's ability to adapt and improve hearing function remains strong even in older adults, as shown by studies that link neural changes to better speech understanding in noisy environments.

Auditory training strategies can significantly enhance speech-in-noise perception and cognitive function, highlighting the importance of tailored treatment approaches for individuals facing hearing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Training: Evidence for Neural Plasticity in Older Adults. Anderson, S., Kraus, N.[2022]

Auditory training (AT) is a crucial rehabilitation method for patients with central auditory processing disorder (CAPD), helping to address specific auditory deficits through targeted protocols.

Current research indicates that AT is effective in improving auditory difficulties in individuals with CAPD, although more data is needed to fully establish its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Training for Central Auditory Processing Disorder. Weihing, J., Chermak, GD., Musiek, FE.[2020]

Citations

1. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1589117/full

The auditory outcomes in non-blast related traumatic brain ... This review aimed to investigate common auditory outcomes associated with TBI and explore variations based on severity, aetiology, and gender.

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-10-92

A “virtually minimal” visuo-haptic training of attention in severe ... Interactive visuo-haptic environments could be beneficial for attention training for severe TBI patients in the early stages of recovery and ...

3. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-8-2024-a15d7

Auditory Plasticity Training for Traumatic Brain Injury Individuals with mild traumatic brain injury showed significant improvements in behavioral tests of central auditory processing six months after completing ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11944267/

Efficacy of Neurorehabilitation Approaches in Traumatic Brain ... Participants achieved successful control, with TBI participants using high-gamma signals demonstrating an average success rate of 62% across trials. Over time, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322005330

Update on the Efficacy of Cognitive Rehabilitation After ... This scoping review highlights the persistent and growing interest in cognitive rehabilitation with major methodological improvements in the design of studies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12288686/

The auditory outcomes in non-blast related traumatic brain ... Normal hearing (≤ 20/25 dB HL) was reported in 31% (19/61) of the studies, however, five studies found abnormal results in central auditory tests despite normal ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028393215300294

Impaired auditory selective attention ameliorated by ... Impaired auditory selective attention ameliorated by cognitive training with graded exposure to noise in patients with traumatic brain injury. Author links ...

8. mdpi.com mdpi.com/2673-4087/3/1/4

A Retrospective Study of the Effects of Traumatic Brain ... There was no statistically significant correlation between the number of auditory tests failed and the number, type, and severity of TBIs.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6475843/

A Review of the Role of Auditory Evoked Potentials in Mild ... It is suspected that persistent attention and memory impairments accompanying TBI may lead to an impaired auditory sensory gating regardless of severity.