Effects of Training on Central Auditory Function in Multiple Sclerosis

VA Office of Research and Development

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Auditory training; Other: MS: Control Activity

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01023074

NCRAR-VA-04-1205 (Other Identifier)

B4762-R

OHSU - 3188 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups, including a placebo group

Non-MS Control

No Intervention group

Description:

Non-MS control group

MS: Auditory Training

Active Comparator group

Description:

MS group receiving auditory training

Treatment:

Behavioral: Auditory training

MS: Control Activity

Placebo Comparator group

Description:

MS group not receiving auditory training, doing control activity

Treatment:

Other: MS: Control Activity