Multiple Sclerosis
Conditions
Keywords
MS, CAP
Brief summary
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
Detailed description
Five general types of evaluations will be employed over multiple study sessions at the National Center for Rehabilitative Auditory Research (NCRAR). First, a neurologist will review the subject's medical history and perform a neurologic exam to confirm MS diagnosis. Second, peripheral auditory function will be evaluated using a standard set of routine audiometric tests. Additionally, subjects will complete a case history and series of hearing handicap inventories. Third, a battery of behavioral procedures will be used to characterize central auditory processing. Fourth, auditory evoked potential studies will be performed. Emphasis here will be upon evoked potentials whose putative neural generators lie within the central auditory nervous system. Fifth, subjects will receive magnetic resonance imaging (MRI) evaluation to determine sites and amount of neural degeneration.
Interventions
BEHAVIORALAuditory training
the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.
OTHERMS: Control Activity
MS group not receiving auditory training, doing control activity
Sponsors
Oregon Health and Science University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* age 21-65 years; * a clinical or laboratory supported diagnosis of definite MS; * a diagnosis of relapsing-remitting, primary progressive, or secondary progressive MS; * a Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive; * no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and * a brain MRI scan that shows at least three white-matter lesions on T2-weighted images consistent with MS
Exclusion criteria
* current major disease or disorder other than MS (e.g., cancer, end-stage renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, diabetes); * other neurological conditions that could interfere with the ability to respond to tests and questionnaires; * non-native speaker of English (since test materials are presented in English); * pregnant (due to potential negative effects on the fetus during fMRI); * more than a mild degree (less than a 40 dB HL four-frequency pure-tone average \[PTA\]) of hearing loss bilaterally (since the presence of more than a mild degree of peripheral hearing impairment may impact CAP test results); * metal implants (due to fMRI constraints); and * left-handedness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrophysiological Auditory Test | Recordings were conducted during one session | auditory P300 amplitude in response to rare 1000 Hz tones |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neural Magnetic Resonance Imaging (MRI) | Results were recorded during one scanning session | Gray matter volume |
| SCAN-A: Competing Words Test | Test administered during one session | The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-MS Control Non-MS control group | 26 |
| MS:Auditory Training MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued. | 13 |
| MS: Control Activity MS group not receiving auditory training, doing control activity
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued. | 13 |
| Total | 52 |
Baseline characteristics
| Characteristic | Non-MS Control | MS:Auditory Training | MS: Control Activity | Total |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 12.5 | 52.0 years STANDARD_DEVIATION 9.6 | 53.0 years STANDARD_DEVIATION 10 | 47.85 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 10 Participants | 35 Participants |
| Sex: Female, Male Male | 11 Participants | 3 Participants | 3 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 26 | 0 / 13 | 0 / 13 |
Outcome results
Primary
Electrophysiological Auditory Test
auditory P300 amplitude in response to rare 1000 Hz tones
Time frame: Recordings were conducted during one session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Electrophysiological Auditory Test | 13.1 microvolts | Standard Deviation 6.7 |
| Arm 2 | Electrophysiological Auditory Test | 6.4 microvolts | Standard Deviation 4 |
| Arm 3 | Electrophysiological Auditory Test | 6.6 microvolts | Standard Deviation 4.4 |
Secondary
Neural Magnetic Resonance Imaging (MRI)
Gray matter volume
Time frame: Results were recorded during one scanning session
Population: Data reported for 47 study participants who underwent MRI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Neural Magnetic Resonance Imaging (MRI) | 1065 cubic cm | Standard Deviation 17 |
| Arm 2 | Neural Magnetic Resonance Imaging (MRI) | 990 cubic cm | Standard Deviation 22 |
| Arm 3 | Neural Magnetic Resonance Imaging (MRI) | 990 cubic cm | Standard Deviation 22 |
Secondary
SCAN-A: Competing Words Test
The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.
Time frame: Test administered during one session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | SCAN-A: Competing Words Test | 10.5 units on a scale | Standard Deviation 2.2 |
| Arm 2 | SCAN-A: Competing Words Test | 7.5 units on a scale | Standard Deviation 3.7 |
| Arm 3 | SCAN-A: Competing Words Test | 7.5 units on a scale | Standard Deviation 3.7 |