Effects of Training on Central Auditory Function in Multiple Sclerosis

NCT ID: NCT01023074

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-06-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Non-MS Control

Non-MS control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

MS: Auditory Training

MS group receiving auditory training

Group Type: ACTIVE_COMPARATOR

Auditory training

Intervention Type: BEHAVIORAL

the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS: Control Activity

MS group not receiving auditory training, doing control activity

Group Type: PLACEBO_COMPARATOR

MS: Control Activity

Intervention Type: OTHER

MS group not receiving auditory training, doing control activity

Interventions

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.

Intervention Type: BEHAVIORAL

MS: Control Activity

MS group not receiving auditory training, doing control activity

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis N. Bourdette, MD

Role: PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Portland, OR

Locations

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCRAR-VA-04-1205

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU - 3188

Identifier Type: OTHER

Identifier Source: secondary_id

B4762-R

Identifier Type: -

Identifier Source: org_study_id