Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
NCT00930774, Not applicable, Completed, US Department of Veterans Affairs; results first posted 2014-06-11
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury | ClinicalTrials.gov |
| NCT number | NCT00930774 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 99 participants, actual | ClinicalTrials.gov |
| Lead sponsor | US Department of Veterans Affairs | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury | ClinicalTrials.gov |
| Interventions | FM system, Auditory training | ClinicalTrials.gov |
| First posted | 2009-06-30 | ClinicalTrials.gov |
| Last updated | 2014-06-11 | ClinicalTrials.gov |
| Results first posted | 2014-06-11 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) | 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 | ClinicalTrials.gov |
| Primary | Stroop Color and Word Test | 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 | ClinicalTrials.gov |
| Secondary | Hearing in Noise Test | 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. | ClinicalTrials.gov |
| Secondary | Staggered Spondaic Word Test | 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. | ClinicalTrials.gov |
| Secondary | Digit Span Score Measure of Auditory Working Memory | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C) | 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. | ClinicalTrials.gov |
Outcomes 8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) | Immediately post-intervention between weeks 8 and 12 | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Color and Word Test | Baseline and Immediately post-intervention (between weeks 8 and 12). | 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. | t-score benefit | MEAN | ClinicalTrials.gov |
| SECONDARY | Hearing in Noise Test | Immediately post-intervention between weeks 8 and 12. | 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. | Decibels (signal to noise ratio) | MEAN | ClinicalTrials.gov |
| SECONDARY | Staggered Spondaic Word Test | Immediately post-intervention between weeks 8 and 12. | 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. | total errors | MEAN | ClinicalTrials.gov |
| SECONDARY | Digit Span Score Measure of Auditory Working Memory | Immediately post-intervention between weeks 8 and 12. | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Time Compressed Speech Test (TCST) | Immediately post-intervention between weeks 8 and 12. | 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. | percent correct | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Self Report Questionnaire (CSRQ). | Immediately post-intervention between weeks 8 and 12. | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C) | Immediately post-intervention | 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. | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) | FM System | 0.56 | Standard Deviation 0.55 | units on a scale | ClinicalTrials.gov | |
| Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) | Auditory Training | .37 | Standard Deviation .52 | units on a scale | ClinicalTrials.gov | |
| Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) | FM System + Auditory Training | .62 | Standard Deviation .61 | units on a scale | ClinicalTrials.gov | |
| Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) | Standard-of-care | .41 | Standard Deviation .76 | units on a scale | ClinicalTrials.gov | |
| Stroop Color and Word Test | FM System | 1.2 | Standard Deviation 11.5 | t-score benefit | ClinicalTrials.gov | |
| Stroop Color and Word Test | Auditory Training | 0.4 | Standard Deviation 3.0 | t-score benefit | ClinicalTrials.gov | |
| Stroop Color and Word Test | FM Sytem + Auditory Training | 1.1 | Standard Deviation 5.1 | t-score benefit | ClinicalTrials.gov | |
| Stroop Color and Word Test | Standard-of-care | 1.6 | Standard Deviation 10.6 | t-score benefit | ClinicalTrials.gov | |
| Hearing in Noise Test | FM System | -8.1 | Standard Deviation 3.2 | Decibels (signal to noise ratio) | ClinicalTrials.gov | |
| Hearing in Noise Test | Auditory Training | -8.1 | Standard Deviation 2.0 | Decibels (signal to noise ratio) | ClinicalTrials.gov | |
| Hearing in Noise Test | FM System + Auditory Training | -8.2 | Standard Deviation 4.3 | Decibels (signal to noise ratio) | ClinicalTrials.gov | |
| Hearing in Noise Test | Standard-of-care | -7.9 | Standard Deviation 2.6 | Decibels (signal to noise ratio) | ClinicalTrials.gov | |
| Staggered Spondaic Word Test | FM System | 5.1 | Standard Deviation 5.5 | total errors | ClinicalTrials.gov | |
| Staggered Spondaic Word Test | Auditory Training | 2.6 | Standard Deviation 2.7 | total errors | ClinicalTrials.gov | |
| Staggered Spondaic Word Test | FM System + Auditory Training | 5.2 | Standard Deviation 8.6 | total errors | ClinicalTrials.gov | |
| Staggered Spondaic Word Test | Standard-of-care | 5.3 | Standard Deviation 6.6 | total errors | ClinicalTrials.gov | |
| Digit Span Score Measure of Auditory Working Memory | FM System | 16 | Standard Deviation 5.0 | units on a scale | ClinicalTrials.gov | |
| Digit Span Score Measure of Auditory Working Memory | Auditory Training | 17.5 | Standard Deviation 3.5 | units on a scale | ClinicalTrials.gov | |
| Digit Span Score Measure of Auditory Working Memory | FM System + Auditory Training | 16.1 | Standard Deviation 4.6 | units on a scale | ClinicalTrials.gov | |
| Digit Span Score Measure of Auditory Working Memory | Standard-of-care | 16.4 | Standard Deviation 3.3 | units on a scale | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | FM System | 25 | ClinicalTrials.gov | |
| Overall Study | STARTED | Auditory Training | 25 | ClinicalTrials.gov | |
| Overall Study | STARTED | FM System and Auditory Training | 24 | ClinicalTrials.gov | |
| Overall Study | STARTED | Standard-of-Care | 25 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | FM System | 24 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Auditory Training | 16 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | FM System and Auditory Training | 22 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Standard-of-Care | 25 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | FM System | 1 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Auditory Training | 9 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | FM System and Auditory Training | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Standard-of-Care | 0 | ClinicalTrials.gov |
Adverse events 4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Participant reported mild headache following research visit at week 8 | General disorders | FM System | 0 | 25 | 0 | ClinicalTrials.gov |
| other | Participant reported mild headache following research visit at week 8 | General disorders | Auditory Training | 0 | 25 | 0 | ClinicalTrials.gov |
| other | Participant reported mild headache following research visit at week 8 | General disorders | FM System + Auditory Training | 0 | 24 | 0 | ClinicalTrials.gov |
| other | Participant reported mild headache following research visit at week 8 | General disorders | Standard-of-care | 1 | 25 | 1 | ClinicalTrials.gov |
Adverse event totals 12
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | FM System | ClinicalTrials.gov | ||
| Total, all-cause mortality | Auditory Training | ClinicalTrials.gov | ||
| Total, all-cause mortality | FM System + Auditory Training | ClinicalTrials.gov | ||
| Total, all-cause mortality | Standard-of-care | ClinicalTrials.gov | ||
| Total, other adverse events | FM System | 0 | 25 | ClinicalTrials.gov |
| Total, other adverse events | Auditory Training | 0 | 25 | ClinicalTrials.gov |
| Total, other adverse events | FM System + Auditory Training | 0 | 24 | ClinicalTrials.gov |
| Total, other adverse events | Standard-of-care | 1 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | FM System | 0 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | Auditory Training | 0 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | FM System + Auditory Training | 0 | 24 | ClinicalTrials.gov |
| Total, serious adverse events | Standard-of-care | 0 | 25 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 26237266 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Dichotic Listening Task | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)