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| ID | Type | Description | Link |
|---|---|---|---|
| NCRAR-VA-04-1205 | Other Identifier | Portland VA Medical Center IRB | |
| OHSU - 3188 | Other Identifier | Oregon Health Sciences University IRB |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-MS Control | No Intervention | Non-MS control group | |
| MS: Auditory Training | Active Comparator | MS group receiving auditory training |
|
| MS: Control Activity | Placebo Comparator | MS group not receiving auditory training, doing control activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory training | Behavioral | the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electrophysiological Auditory Test | auditory P300 amplitude in response to "rare" 1000 Hz tones | Recordings were conducted during one session |
| Measure | Description | Time Frame |
|---|---|---|
| Neural Magnetic Resonance Imaging (MRI) | Gray matter volume | Results were recorded during one scanning session |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis N. Bourdette, MD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-MS Control | Non-MS control group |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-MS Control | Non-MS control group |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Electrophysiological Auditory Test | auditory P300 amplitude in response to "rare" 1000 Hz tones | Posted | Mean | Standard Deviation | microvolts | Recordings were conducted during one session |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-MS Control | Non-MS control group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Folmer, Ph.D. | Portland VA Medical Center | 503-220-8262 | 51868 | Robert.Folmer@va.gov |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| MS: Control Activity | Other | MS group not receiving auditory training, doing control activity |
|
| Test administered during one session |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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.
|
|
| Secondary | Neural Magnetic Resonance Imaging (MRI) | Gray matter volume | Data reported for 47 study participants who underwent MRI | Posted | Mean | Standard Deviation | cubic cm | Results were recorded during one scanning session |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Test administered during one session |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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. | 0 | 13 | 0 | 13 |
| EG002 | 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. | 0 | 13 | 0 | 13 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |