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Auditory Function in Patients With and Without Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hearing in Multiple Sclerosis
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Hearing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Multiple Sclerosis

Sites / Locations

  • VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
June 2, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00037947
Brief Title
Auditory Function in Patients With and Without Multiple Sclerosis
Official Title
Auditory Function in Patients With and Without Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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: Evaluating the possibility that MS is a risk factor for hearing impairment, tinnitus and central auditory dysfunction. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, MS, Hearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hearing in Multiple Sclerosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Multiple Sclerosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wolff, Ph.D. Special Assistant to the Director
Organizational Affiliation
Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Danielle Kerkovitch, Ph.D.
Organizational Affiliation
Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
Facility Information:
Facility Name
VA Medical Center
City
Portland
State/Province
Oregon
Country
United States

12. IPD Sharing Statement

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Auditory Function in Patients With and Without Multiple Sclerosis

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