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Effects of Training on Central Auditory Function in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01023074
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : March 17, 2015
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Auditory training Other: MS: Control Activity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Training on Central Auditory Function in Multiple Sclerosis
Study Start Date : October 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Non-MS Control
Non-MS control group
Active Comparator: MS: Auditory Training
MS group receiving auditory training
Behavioral: 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.

Placebo Comparator: MS: Control Activity
MS group not receiving auditory training, doing control activity
Other: MS: Control Activity
MS group not receiving auditory training, doing control activity




Primary Outcome Measures :
  1. Electrophysiological Auditory Test [ Time Frame: Recordings were conducted during one session ]
    auditory P300 amplitude in response to "rare" 1000 Hz tones


Secondary Outcome Measures :
  1. Neural Magnetic Resonance Imaging (MRI) [ Time Frame: Results were recorded during one scanning session ]
    Gray matter volume

  2. SCAN-A: Competing Words Test [ Time Frame: Test administered during one session ]
    The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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 ClinicalTrials.gov identifier (NCT number): NCT01023074


Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
Oregon Health and Science University
Investigators
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Principal Investigator: Dennis N. Bourdette, MD VA Portland Health Care System, Portland, OR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01023074     History of Changes
Other Study ID Numbers: B4762-R
NCRAR-VA-04-1205 ( Other Identifier: Portland VA Medical Center IRB )
OHSU - 3188 ( Other Identifier: Oregon Health Sciences University IRB )
First Posted: December 2, 2009    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: October 9, 2018
Last Verified: September 2018
Keywords provided by VA Office of Research and Development:
MS
CAP
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases