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Clinical Trials/NCT00037947
NCT00037947
Completed
Phase 2

Auditory Function in Patients With and Without Multiple Sclerosis

US Department of Veterans Affairs1 site in 1 country300 target enrollmentOctober 2001

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
US Department of Veterans Affairs
Enrollment
300
Locations
1
Status
Completed
Last Updated
17 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
December 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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