Traumatic Brain InjurymTBINCT00930774
Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
A study testing FM system and Auditory training in people with Traumatic Brain Injury, run by US Department of Veterans Affairs at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- FM system and Auditory training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Medical Center, Portland
Portland, Oregon, 97201
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
About this study
Official title: Evaluation of Approaches to Auditory Rehabilitation for Mild TBI
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- FM system, Auditory training
- Keywords
- traumatic brain injury, rehabilitation, auditory processing disorder
- Medical subject headings
- Brain Injuries, Traumatic, Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM systemDevice
Frequency modulation assistive device
Auditory trainingBehavioural
Participation in computerized auditory training program for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| FM System | Experimental | Provision of FM assistive device Receives: Device: FM system |
| Auditory Training | Experimental | Provision of auditory training Receives: Behavioral: Auditory training |
| FM System and Auditory Training | Experimental | Provision of FM assistive device and auditory training Receives: Device: FM system; Behavioral: Auditory training |
| Standard-of-Care | No intervention | Standard-of-care informational counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and Immediately post-intervention (between weeks 8 and 12).
Secondary outcomes (6)
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.
Measured: Immediately post-intervention between weeks 8 and 12.
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.
Measured: Immediately post-intervention between weeks 8 and 12.
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.
Measured: Immediately post-intervention between weeks 8 and 12.
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.
Measured: Immediately post-intervention between weeks 8 and 12.
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.
Measured: Immediately post-intervention between weeks 8 and 12.
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gabrielle Saunders, Principal investigator, VA Medical Center, Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930774
- Sponsor's protocol ID
- C7054-R
- Other IDs
- 02386, 11-1808
- Acronym
- mTBI
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2009
- Last updated
- 11 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26237266
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Approaches to Auditory Rehabilitation for Mild TBI
- ClinicalTrials.gov ID
- NCT00930774
- Acronym / sponsor ID
- mTBI / C7054-R
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, rehabilitation, auditory processing disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FM System | Experimental | Device: FM systemProvision of FM assistive device |
| Auditory Training | Experimental | Behavioral: Auditory trainingProvision of auditory training |
| FM System and Auditory Training | Experimental | Device: FM system, Behavioral: Auditory trainingProvision of FM assistive device and auditory training |
| Standard-of-Care | No intervention | –Standard-of-care informational counseling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FM systemFrequency modulation assistive device | Device | FM System, FM System and Auditory Training |
| Auditory trainingParticipation in computerized auditory training program for eight weeks | Behavioural | Auditory Training, FM System and Auditory Training |
Primary outcome
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
6 secondary outcomes
Hearing in Noise Test
Time frame: Immediately post-intervention between weeks 8 and 12.
Staggered Spondaic Word Test
Time frame: Immediately post-intervention between weeks 8 and 12.
Digit Span Score Measure of Auditory Working Memory
Time frame: Immediately post-intervention between weeks 8 and 12.
Time Compressed Speech Test (TCST)
Time frame: Immediately post-intervention between weeks 8 and 12.
Cognitive Self Report Questionnaire (CSRQ).
Time frame: Immediately post-intervention between weeks 8 and 12.
Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)
Time frame: Immediately post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26237266Saunders 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle Saunders principal investigator
VA Medical Center, Portland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FM system and Auditory training in people with Traumatic Brain Injury, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) (time frame: Immediately post-intervention between weeks 8 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.