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Home > "A" Clinical Trials Conditions > Auditory Function in Patients With and Without Multiple Sclerosis  Auditory Function in Patients With and Without Multiple Sclerosis
Auditory Function in Patients With and Without Multiple Sclerosis
For Condition: Multiple Sclerosis
Status: Recruiting
Sponsor(s): Department of Veterans Affairs Rehabilitation Research and Development Service ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Multiple Sclerosis
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
DavidWolff, , Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
VA Medical Center *Recruiting*
Portland, Oregon,
United States
Recruiting David Lilly 503-220-8262
Additional Information:
Study ID Numbers: B2568;
Study Start Date: October 2001
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037947
Other Multiple Sclerosis Studies:
1. Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)
2. Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
3. Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
4. Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)
5. Treatment of Multiple Sclerosis with Copaxone and Albuterol
Related Studies:
Other Multiple Sclerosis Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Auditory Function in Patients With and Without Multiple Sclerosis
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