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Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury

Evaluation of Approaches to Auditory Rehabilitation for Mild TBI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00930774
Acronym
mTBI
Enrollment
99
Registered
2009-06-30
Start date
2010-10-31
Completion date
2012-12-31
Last updated
2014-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, rehabilitation, auditory processing disorder

Brief summary

Many soldiers returning from their recent service in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) were exposed to blasts during combat. About 60% of blast-injured soldiers are diagnosed with traumatic brain injury (TBI), with approximately 18% having a mild TBI (mTBI). mTBI is associated with many symptoms, including memory problems, headaches, difficulty concentrating, increased anxiety, and, especially relevant here, reports of difficulty understanding speech in noisy environments and/or when people speak rapidly. While problems understanding rapid speech or speech in noise are associated with hearing loss, many of the OIF/OEF veterans with these complaints have clinically normal hearing. Although there is no physical damage to their ears, these veterans' hearing problems have a negative impact on their quality-of-life and functioning. Thus it is incumbent upon the VA to examine intervention approaches for veterans with normal/near-normal auditory sensitivity and significant complaints of difficulty hearing. Currently, there is no standard-of-care for these veterans other than providing information about hearing, hearing conservation, and the use of communication strategies. Two forms of rehabilitation likely to be more effective than such an informational-counseling approach are: (1) the use of personal miniaturized Frequency modulation (FM) systems, and (2) the provision of auditory training with Posit Science Brain Fitness Program (BFP). Personal FM systems increase the loudness of the speech signal relative to that of the unwanted noise, while the BFP training improves the ability to listen by taking advantage of the brain's ability to change (i.e., neural plasticity). In this study veterans will randomly be selected to receive one of four treatments: (1) FM use alone, (2) BFP training alone, (3) FM+BFP training combined, and (4) informational-counseling. The effectiveness of the interventions will be compared using self-report of hearing functioning on standard questionnaires. Results will contribute to the development of evidence-based intervention approaches for blast-exposed veterans with reported functional hearing difficulties and normal/near-normal auditory sensitivity.

Detailed description

The long-term goal of this study is to develop evidence-based auditory rehabilitation for veterans who have normal/near-normal peripheral auditory function and significant complaints of difficulty hearing. Many are veterans of the OIF/OEF conflicts who have been exposed to blast - the most common wounding etiology in these conflicts. Approximately 18% of blast-injured veterans are diagnosed with mild traumatic brain injury (mTBI). mTBI can result in post-concussive symptoms such as memory problems, difficulty concentrating, increased anxiety, and functional hearing difficulties in the presence of clinically-normal hearing sensitivity. Currently there is no standard-of-care auditory rehabilitation for veterans with normal/near-normal auditory sensitivity and complaints of difficulty hearing. At a minimum, the VA recommends provision of information about the auditory system, hearing conservation and use of communication strategies. Two interventions likely to be more efficacious are: (1) use of personal FM (frequency modulation) systems, and/or (2) auditory training. FM systems are effective for managing auditory problems in children with normal/near normal peripheral hearing. FM systems substantially improve the signal-to-noise ratio of speech in noisy and reverberant environments, theoretically making more resources available for higher level processing. Auditory training takes advantage of neural plasticity. The Posit Science Brain Fitness Program (BFP) is an auditory training program for adults that can improve temporal processing and working memory of older adults. Combining use of FM systems with auditory training has been shown to improve speech understanding and to decrease reported hearing abilities among adults with sensorineural hearing loss and functional hearing complaints. No study has systemically examined the relative efficacy of FM use and/or auditory training for veterans with mTBI and normal/almost normal hearing sensitivity. The effectiveness of these two intervention strategies will be examined in this study through a between-subjects randomized controlled clinical trial comparing the outcomes of: (1) FM use alone, (2) BFP alone, and (3) FM+BFP combined. All groups will also receive informational-counseling, as will (4) a control group. Outcomes will be measured subjectively through self-report of auditory competence. The results of the study will help to determine whether or not the use of FM systems or auditory training, either alone or combined, are efficacious interventions for blast-exposed veterans with reported functional hearing difficulties and normal/near-normal auditory sensitivity. Results will contribute to the development of evidence-based auditory rehabilitation for these veterans, moving VA closer to fulfilling its goal of providing excellence in patient care, veterans' benefits and customer satisfaction.

Interventions

DEVICEFM system

Frequency modulation assistive device

Participation in computerized auditory training program for eight weeks

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Participants will be OIF/OEF veterans with no exclusions based on age, ethnicity, or gender. To be included in the study participants will: * Report difficulty understanding speech in difficult listening environments disproportionate to loss in hearing sensitivity, as defined by self-referral to the study * Have hearing thresholds \<= 65 decibels hearing loss (dB HL) at 0.5, 1.0, 2.0, 3.0 & 4.0 kilohertz (kHz) * Cognitive abilities sufficient to participate in the study, as determined by an age and education-level appropriate score on the Mini Mental State Exam (MMSE; Folstein, Robins, & Helzer, 1983; Crum et al., 1993), * English as a first language, * Openness to using a personal FM system for a four-week period and/or to conducting auditory training over an eight-week period, as determined through interview.

Exclusion criteria

* Asymmetric pure tone thresholds (left-right difference \> 15 dB HL at frequencies of 500 through 4000 Hz), * Presence of neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review, * Best corrected vision worse than 20/63 as measured with the Smith-Kettlewell Institute Low Luminance (SKILL) Card

Design outcomes

Primary

MeasureTime frameDescription
Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)Immediately post-intervention between weeks 8 and 12Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change
Stroop Color and Word TestBaseline and Immediately post-intervention (between weeks 8 and 12).Measure of processing interference that assesses the ability to cope with cognitive stress and process complex input. It consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a Color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The test-taker looks at each sheet and moves down the columns, reading words or naming the ink colors as quickly as possible within a time limit. Interference raw scores were converted into t-scores for analysis. T-score benefit was the analytic metric used. T-score benefit = post-intervention score minus baseline score

Secondary

MeasureTime frameDescription
Digit Span Score Measure of Auditory Working MemoryImmediately post-intervention between weeks 8 and 12.The Digit Span subtest of the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III) assessed auditory working memory. It consists of a Digit Span Forward task in which individuals to repeat numbers in the same sequence as they were presented verbally, and a Digit Span Backward task in which individuals repeat back the numbers in the reverse order to which they were heard. Data are summed to compute a Digit Span total score. Possible range of scores is 0 to 30, with higher scores indicating better performance.
Time Compressed Speech Test (TCST)Immediately post-intervention between weeks 8 and 12.the TCST assessed speech recognition for speeded speech. Sentences are presented in the sound field in quiet at with 50% and 60% time compression. Participants repeat back each sentence after it is presented.
Hearing in Noise TestImmediately post-intervention between weeks 8 and 12.Hearing In Noise Test assesses speech understanding in noise assessed. Sentences are presented in a background of noise. The signal to noise ratio is varied adaptively to obtained the signal to noise ratio at which participants can correctly repeat back 50% of sentences presented in speech-shaped noise is determined. A lower signal to noise ratio indicates better performance.
Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)Immediately post-interventionThree subscale questionnaire that examines reported change in auditory disability for Speech, Spatial hearing and Quality of sounds. Subjects respond on a scale of -5 ('much worse') to +5 (much better) to indicate the change in difficulties following an intervention they have hearing in specific situations, with a lower number indicating greater difficulty. Results are presented for average total SSQ-C score which can range from -5 to +5, with higher scores indicating greater improvement.
Cognitive Self Report Questionnaire (CSRQ).Immediately post-intervention between weeks 8 and 12.CSRQ assesses self-reported cognitive difficulties in 8 domains: Attention, Executive function, Memory, Language, Vision, Hearing, Energy,and Satisfaction. Participants respond on a 3-point Likert scale whether they perceived they improved, remained the same, or got worse as a result of an intervention. Total score is computed by summing scores on each subscale. Range for total score = -64 to +64, with higher scores indicating fewer reported cognitive difficulties.
Staggered Spondaic Word TestImmediately post-intervention between weeks 8 and 12.Dichotic listening test in which two spondaic words are presented, one to each ear of the listener, in an overlapping fashion such that the first syllable of the first word is presented in isolation, the second syllable of the first word is presented simultaneously with the first syllable of the second word, and the second syllable of the second word is presented in isolation. Total number of test spondee pairs = 40.

Countries

United States

Participant flow

Participants by arm

ArmCount
FM System
Provision of FM assistive device FM system: Frequency modulation assistive device
25
Auditory Training
Provision of auditory training Auditory training: Participation in computerized auditory training program for eight weeks
25
FM System + Auditory Training
Provision of FM assistive device and auditory training FM system: Frequency modulation assistive device Auditory training: Participation in computerized auditory training program for eight weeks
24
Standard-of-Care
Standard-of-care informational counseling
25
Total99

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject1920

Baseline characteristics

CharacteristicAuditory TrainingTotalFM SystemStandard-of-CareFM System + Auditory Training
Age, Continuous33.9 years
STANDARD_DEVIATION 9.2
34.0 years
STANDARD_DEVIATION 8.1
34.4 years
STANDARD_DEVIATION 7.8
33.7 years
STANDARD_DEVIATION 8
33.9 years
STANDARD_DEVIATION 7.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants10 Participants1 Participants4 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants87 Participants23 Participants21 Participants20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants0 Participants0 Participants
Pure tone sensitivity12.0 Decibels hearing level
STANDARD_DEVIATION 5.3
12.2 Decibels hearing level
STANDARD_DEVIATION 5.1
12.3 Decibels hearing level
STANDARD_DEVIATION 6.1
12.1 Decibels hearing level
STANDARD_DEVIATION 4.4
12.9 Decibels hearing level
STANDARD_DEVIATION 5.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants11 Participants4 Participants4 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
22 Participants83 Participants19 Participants21 Participants21 Participants
Sex: Female, Male
Female
3 Participants11 Participants5 Participants3 Participants0 Participants
Sex: Female, Male
Male
22 Participants88 Participants20 Participants22 Participants24 Participants
Word recognition score95.2 percent correct
STANDARD_DEVIATION 5.4
95.9 percent correct
STANDARD_DEVIATION 4.7
95.5 percent correct
STANDARD_DEVIATION 5.8
95.6 percent correct
STANDARD_DEVIATION 3.9
97.3 percent correct
STANDARD_DEVIATION 2.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 250 / 250 / 241 / 25
serious
Total, serious adverse events
0 / 250 / 250 / 240 / 25

Outcome results

Primary

Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)

Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change

Time frame: Immediately post-intervention between weeks 8 and 12

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemCompetence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)0.56 units on a scaleStandard Deviation 0.55
Auditory TrainingCompetence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS).37 units on a scaleStandard Deviation 0.52
FM System + Auditory TrainingCompetence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS).62 units on a scaleStandard Deviation 0.61
Standard-of-careCompetence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS).41 units on a scaleStandard Deviation 0.76
p-value: 0.527ANOVA
Primary

Stroop Color and Word Test

Measure of processing interference that assesses the ability to cope with cognitive stress and process complex input. It consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a Color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The test-taker looks at each sheet and moves down the columns, reading words or naming the ink colors as quickly as possible within a time limit. Interference raw scores were converted into t-scores for analysis. T-score benefit was the analytic metric used. T-score benefit = post-intervention score minus baseline score

Time frame: Baseline and Immediately post-intervention (between weeks 8 and 12).

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemStroop Color and Word Test1.2 t-score benefitStandard Deviation 11.5
Auditory TrainingStroop Color and Word Test0.4 t-score benefitStandard Deviation 3
FM System + Auditory TrainingStroop Color and Word Test1.1 t-score benefitStandard Deviation 5.1
Standard-of-careStroop Color and Word Test1.6 t-score benefitStandard Deviation 10.6
p-value: 0.835ANOVA
Secondary

Cognitive Self Report Questionnaire (CSRQ).

CSRQ assesses self-reported cognitive difficulties in 8 domains: Attention, Executive function, Memory, Language, Vision, Hearing, Energy,and Satisfaction. Participants respond on a 3-point Likert scale whether they perceived they improved, remained the same, or got worse as a result of an intervention. Total score is computed by summing scores on each subscale. Range for total score = -64 to +64, with higher scores indicating fewer reported cognitive difficulties.

Time frame: Immediately post-intervention between weeks 8 and 12.

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemCognitive Self Report Questionnaire (CSRQ).11.5 units on a scaleStandard Deviation 14.1
Auditory TrainingCognitive Self Report Questionnaire (CSRQ).10.3 units on a scaleStandard Deviation 12
FM System + Auditory TrainingCognitive Self Report Questionnaire (CSRQ).17.1 units on a scaleStandard Deviation 16.1
Standard-of-careCognitive Self Report Questionnaire (CSRQ).0 units on a scaleStandard Deviation 18.9
p-value: 0.001ANOVA
p-value: <0.05ANOVA
Secondary

Digit Span Score Measure of Auditory Working Memory

The Digit Span subtest of the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III) assessed auditory working memory. It consists of a Digit Span Forward task in which individuals to repeat numbers in the same sequence as they were presented verbally, and a Digit Span Backward task in which individuals repeat back the numbers in the reverse order to which they were heard. Data are summed to compute a Digit Span total score. Possible range of scores is 0 to 30, with higher scores indicating better performance.

Time frame: Immediately post-intervention between weeks 8 and 12.

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemDigit Span Score Measure of Auditory Working Memory16 units on a scaleStandard Deviation 5
Auditory TrainingDigit Span Score Measure of Auditory Working Memory17.5 units on a scaleStandard Deviation 3.5
FM System + Auditory TrainingDigit Span Score Measure of Auditory Working Memory16.1 units on a scaleStandard Deviation 4.6
Standard-of-careDigit Span Score Measure of Auditory Working Memory16.4 units on a scaleStandard Deviation 3.3
p-value: 0.757ANOVA
Secondary

Hearing in Noise Test

Hearing In Noise Test assesses speech understanding in noise assessed. Sentences are presented in a background of noise. The signal to noise ratio is varied adaptively to obtained the signal to noise ratio at which participants can correctly repeat back 50% of sentences presented in speech-shaped noise is determined. A lower signal to noise ratio indicates better performance.

Time frame: Immediately post-intervention between weeks 8 and 12.

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemHearing in Noise Test-8.1 Decibels (signal to noise ratio)Standard Deviation 3.2
Auditory TrainingHearing in Noise Test-8.1 Decibels (signal to noise ratio)Standard Deviation 2
FM System + Auditory TrainingHearing in Noise Test-8.2 Decibels (signal to noise ratio)Standard Deviation 4.3
Standard-of-careHearing in Noise Test-7.9 Decibels (signal to noise ratio)Standard Deviation 2.6
p-value: 0.983ANOVA
Secondary

Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)

Three subscale questionnaire that examines reported change in auditory disability for Speech, Spatial hearing and Quality of sounds. Subjects respond on a scale of -5 ('much worse') to +5 (much better) to indicate the change in difficulties following an intervention they have hearing in specific situations, with a lower number indicating greater difficulty. Results are presented for average total SSQ-C score which can range from -5 to +5, with higher scores indicating greater improvement.

Time frame: Immediately post-intervention

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemSpeech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)1.0 units on a scaleStandard Deviation 1.2
Auditory TrainingSpeech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)0.4 units on a scaleStandard Deviation 0.6
FM System + Auditory TrainingSpeech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)1.0 units on a scaleStandard Deviation 1.1
Standard-of-careSpeech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)0.3 units on a scaleStandard Deviation 0.7
p-value: 0.013ANOVA
p-value: 0.05ANOVA
Secondary

Staggered Spondaic Word Test

Dichotic listening test in which two spondaic words are presented, one to each ear of the listener, in an overlapping fashion such that the first syllable of the first word is presented in isolation, the second syllable of the first word is presented simultaneously with the first syllable of the second word, and the second syllable of the second word is presented in isolation. Total number of test spondee pairs = 40.

Time frame: Immediately post-intervention between weeks 8 and 12.

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemStaggered Spondaic Word Test5.1 total errorsStandard Deviation 5.5
Auditory TrainingStaggered Spondaic Word Test2.6 total errorsStandard Deviation 2.7
FM System + Auditory TrainingStaggered Spondaic Word Test5.2 total errorsStandard Deviation 8.6
Standard-of-careStaggered Spondaic Word Test5.3 total errorsStandard Deviation 6.6
p-value: 0.554ANOVA
Secondary

Time Compressed Speech Test (TCST)

the TCST assessed speech recognition for speeded speech. Sentences are presented in the sound field in quiet at with 50% and 60% time compression. Participants repeat back each sentence after it is presented.

Time frame: Immediately post-intervention between weeks 8 and 12.

Population: The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.

ArmMeasureValue (MEAN)Dispersion
FM SystemTime Compressed Speech Test (TCST)92.8 percent correctStandard Deviation 4.6
Auditory TrainingTime Compressed Speech Test (TCST)93.8 percent correctStandard Deviation 3.8
FM System + Auditory TrainingTime Compressed Speech Test (TCST)89.5 percent correctStandard Deviation 9.7
Standard-of-careTime Compressed Speech Test (TCST)90.9 percent correctStandard Deviation 9.3
p-value: 0.302ANOVA

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026