Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury (mTBI)
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|ClinicalTrials.gov Identifier: NCT00930774|
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Device: FM system Behavioral: Auditory training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Approaches to Auditory Rehabilitation for Mild TBI|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
Experimental: FM System
Provision of FM assistive device
Device: FM system
Frequency modulation assistive device
Experimental: Auditory Training
Provision of auditory training
Behavioral: Auditory training
Participation in computerized auditory training program for eight weeks
Experimental: FM System and Auditory Training
Provision of FM assistive device and auditory training
Device: FM system
Frequency modulation assistive deviceBehavioral: Auditory training
Participation in computerized auditory training program for eight weeks
No Intervention: Standard-of-Care
Standard-of-care informational counseling
- Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) [ Time Frame: Immediately post-intervention between weeks 8 and 12 ]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
- Stroop Color and Word Test [ Time Frame: Baseline 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
- Hearing in Noise Test [ Time Frame: Immediately 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.
- Staggered Spondaic Word Test [ Time Frame: Immediately 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.
- Digit Span Score Measure of Auditory Working Memory [ Time Frame: Immediately 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) [ Time Frame: 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.
- Cognitive Self Report Questionnaire (CSRQ). [ Time Frame: 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.
- Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C) [ Time Frame: Immediately post-intervention ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930774
|United States, Florida|
|James A. Haley Veterans Hospital, Tampa|
|Tampa, Florida, United States, 33612|
|United States, Oregon|
|VA Medical Center, Portland|
|Portland, Oregon, United States, 97201|
|Principal Investigator:||Gabrielle Saunders||VA Medical Center, Portland|