Effects of Training on Central Auditory Function in Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).

Detailed Description
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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.

Official Title
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Effects of Training on Central Auditory Function in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Auditory training
* Other: MS: Control Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-MS Control<br>Non-MS control group | |
| Active Comparator: MS: Auditory Training<br>MS group receiving auditory training | Behavioral: Auditory training<br>* the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.<br>|
| Placebo Comparator: MS: Control Activity<br>MS group not receiving auditory training, doing control activity | Other: MS: Control Activity<br>* MS group not receiving auditory training, doing control activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological Auditory Test | auditory P300 amplitude in response to rare 1000 Hz tones | Recordings were conducted during one session | 

Secondary Outcome Measures

| Outcome Measure | 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. | Test administered during one session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, CAP