Trial Outcomes & Findings for Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury (NCT NCT00930774)
NCT ID: NCT00930774
Last Updated: 2014-06-11
Results Overview
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
COMPLETED
NA
99 participants
Immediately post-intervention between weeks 8 and 12
2014-06-11
Participant Flow
Participant milestones
| Measure |
FM System
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System and Auditory Training
Provision of frequency modulation (FM) assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks
|
Standard-of-Care
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
24
|
25
|
|
Overall Study
COMPLETED
|
24
|
16
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
2
|
0
|
Reasons for withdrawal
| Measure |
FM System
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System and Auditory Training
Provision of frequency modulation (FM) assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks
|
Standard-of-Care
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
9
|
2
|
0
|
Baseline Characteristics
Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
FM System
n=25 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=25 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=24 Participants
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
|
Standard-of-Care
n=25 Participants
Standard-of-care informational counseling
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Pure tone sensitivity
|
12.3 Decibels hearing level
STANDARD_DEVIATION 6.1 • n=5 Participants
|
12.0 Decibels hearing level
STANDARD_DEVIATION 5.3 • n=7 Participants
|
12.9 Decibels hearing level
STANDARD_DEVIATION 5.4 • n=5 Participants
|
12.1 Decibels hearing level
STANDARD_DEVIATION 4.4 • n=4 Participants
|
12.2 Decibels hearing level
STANDARD_DEVIATION 5.1 • n=21 Participants
|
|
Word recognition score
|
95.5 percent correct
STANDARD_DEVIATION 5.8 • n=5 Participants
|
95.2 percent correct
STANDARD_DEVIATION 5.4 • n=7 Participants
|
97.3 percent correct
STANDARD_DEVIATION 2.8 • n=5 Participants
|
95.6 percent correct
STANDARD_DEVIATION 3.9 • n=4 Participants
|
95.9 percent correct
STANDARD_DEVIATION 4.7 • n=21 Participants
|
PRIMARY outcome
Timeframe: Immediately post-intervention between weeks 8 and 12Population: 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.
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
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)
|
0.56 units on a scale
Standard Deviation 0.55
|
.37 units on a scale
Standard Deviation .52
|
.62 units on a scale
Standard Deviation .61
|
.41 units on a scale
Standard Deviation .76
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Stroop Color and Word Test
|
1.2 t-score benefit
Standard Deviation 11.5
|
0.4 t-score benefit
Standard Deviation 3.0
|
1.1 t-score benefit
Standard Deviation 5.1
|
1.6 t-score benefit
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Hearing in Noise Test
|
-8.1 Decibels (signal to noise ratio)
Standard Deviation 3.2
|
-8.1 Decibels (signal to noise ratio)
Standard Deviation 2.0
|
-8.2 Decibels (signal to noise ratio)
Standard Deviation 4.3
|
-7.9 Decibels (signal to noise ratio)
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Staggered Spondaic Word Test
|
5.1 total errors
Standard Deviation 5.5
|
2.6 total errors
Standard Deviation 2.7
|
5.2 total errors
Standard Deviation 8.6
|
5.3 total errors
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Digit Span Score Measure of Auditory Working Memory
|
16 units on a scale
Standard Deviation 5.0
|
17.5 units on a scale
Standard Deviation 3.5
|
16.1 units on a scale
Standard Deviation 4.6
|
16.4 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Time Compressed Speech Test (TCST)
|
92.8 percent correct
Standard Deviation 4.6
|
93.8 percent correct
Standard Deviation 3.8
|
89.5 percent correct
Standard Deviation 9.7
|
90.9 percent correct
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Cognitive Self Report Questionnaire (CSRQ).
|
11.5 units on a scale
Standard Deviation 14.1
|
10.3 units on a scale
Standard Deviation 12.0
|
17.1 units on a scale
Standard Deviation 16.1
|
0 units on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Immediately post-interventionPopulation: 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.
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.
Outcome measures
| Measure |
FM System
n=24 Participants
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=14 Participants
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=20 Participants
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
|
Standard-of-care
n=22 Participants
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)
|
1.0 units on a scale
Standard Deviation 1.2
|
0.4 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 1.1
|
0.3 units on a scale
Standard Deviation 0.7
|
Adverse Events
FM System
Auditory Training
FM System + Auditory Training
Standard-of-care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FM System
n=25 participants at risk
Provision of FM assistive device
FM system: Frequency modulation assistive device
|
Auditory Training
n=25 participants at risk
Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks
|
FM System + Auditory Training
n=24 participants at risk
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
|
Standard-of-care
n=25 participants at risk
Standard-of-care informational counseling
|
|---|---|---|---|---|
|
General disorders
Participant reported mild headache following research visit at week 8
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
4.0%
1/25 • Number of events 1
|
Additional Information
Dr. Gabrielle H Saunders
National Center for Rehabilitative Auditory Research, Portland VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place