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Auditory Function in Patients With and Without Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037947
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : June 4, 2008
Information provided by:
VA Office of Research and Development

Brief Summary:
We propose to evaluate auditory function and neuropsychologic function in 150 Multiple Sclerosis (MS) patients and in 150 patients who do not have MS. Experimental subjects will be recruited by selecting patients with a verified diagnosis of MS from the registry of patients established by the Oregon Health Sciences University, Multiple Sclerosis Research Center. Control subjects will be matched with respect to age, to gender and to audiometric configuration.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: Hearing in Multiple Sclerosis Phase 2

Detailed Description:

This study will compare the prevalence and nature of hearing dysfunction in patients with MS and in a group of control subjects without MS. The work will address three main goals:

  1. Evaluating the possibility that MS is a risk factor for hearing impairment, tinnitus and central auditory dysfunction.
  2. Determining the nature and the extent of auditory dysfunction in individuals with MS compared to those without MS; and determining neuropsychological function in each group.
  3. Evaluating the extent to which disability in individuals with MS may be amplified by the presence of auditory dysfunction.

Measurements of auditory function and psychometric performance will be compared between MS patients and control subjects without MS. These subjects will come to the Portland VAMC for four sessions of comprehensive auditory and psychometric testing. Additional information on disease history and status, hearing history, and current-disability status will be obtained.

Subjects The patient group (Group 1) will consist of 150 patients with diagnosed MS, recruited at the MS Center of Oregon. For this group, inclusion criteria for each patient will include: (1) a clinical or laboratory supported diagnosis of "definite MS" (Poser, et al., 1983); (2) a diagnosis of relapsing, remitting or secondary progressive MS; (3) A Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive; (4) no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and (5) a brain MRI scan (within the preceding year) that shows at least three white-matter lesions on T2-weighted images consistent with MS.

The control group (Group 2) will consist of 150 subjects without MS who are matched to the patient group with respect to age (± 5 years), to gender and to audiometric configuration (within ±10 dB Hearing Level for the octave test frequencies from 500 through 8000 Hz). Subjects in Group 2 will be recruited from the VA audiology clinic and from a cohort of more than 360 subjects and patients who have been used as controls in five other studies. Both males and non-pregnant females will be recruited in equal numbers. Minority individuals will be recruited in accordance with recommendations for proportional minority representation established by the Office of Human Research Accountability and the Minority Affairs Program. The protocols will be explained verbally by the investigators, and restated in consent forms approved by the VA IRB, and signed by the subject, by the investigator and by a witness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Auditory Function in Patients With and Without Multiple Sclerosis
Study Start Date : October 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Multiple Sclerosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00037947

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United States, Oregon
VA Medical Center
Portland, Oregon, United States
Sponsors and Collaborators
US Department of Veterans Affairs
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OverallOfficial: David Wolff, Ph.D. Special Assistant to the Director Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
OverallOfficial: Danielle Kerkovitch, Ph.D. Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service

Layout table for additonal information Identifier: NCT00037947    
Other Study ID Numbers: B2568R
First Posted: May 27, 2002    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by VA Office of Research and Development:
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases