Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
mTBI
Evaluation of Approaches to Auditory Rehabilitation for Mild TBI
3 other identifiers
interventional
99
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
June 11, 2014
CompletedJune 11, 2014
June 1, 2014
2 years
June 26, 2009
February 21, 2014
June 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Immediately post-intervention between weeks 8 and 12
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
Baseline and Immediately post-intervention (between weeks 8 and 12).
Secondary Outcomes (6)
Hearing in Noise Test
Immediately post-intervention between weeks 8 and 12.
Staggered Spondaic Word Test
Immediately post-intervention between weeks 8 and 12.
Digit Span Score Measure of Auditory Working Memory
Immediately post-intervention between weeks 8 and 12.
Time Compressed Speech Test (TCST)
Immediately post-intervention between weeks 8 and 12.
Cognitive Self Report Questionnaire (CSRQ).
Immediately post-intervention between weeks 8 and 12.
- +1 more secondary outcomes
Study Arms (4)
FM System
EXPERIMENTALProvision of FM assistive device
Auditory Training
EXPERIMENTALProvision of auditory training
FM System and Auditory Training
EXPERIMENTALProvision of FM assistive device and auditory training
Standard-of-Care
NO INTERVENTIONStandard-of-care informational counseling
Interventions
Participation in computerized auditory training program for eight weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
VA Medical Center, Portland
Portland, Oregon, 97201, United States
Related Publications (1)
Saunders GH, Frederick MT, Arnold M, Silverman S, Chisolm TH, Myers P. Auditory difficulties in blast-exposed Veterans with clinically normal hearing. J Rehabil Res Dev. 2015;52(3):343-60. doi: 10.1682/JRRD.2014.11.0275.
PMID: 26237266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gabrielle H Saunders
- Organization
- National Center for Rehabilitative Auditory Research, Portland VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gabrielle Saunders
VA Medical Center, Portland
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 30, 2009
Study Start
October 1, 2010
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
June 11, 2014
Results First Posted
June 11, 2014
Record last verified: 2014-06