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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

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 2, 2009
Results First Submitted Date  ICMJE January 29, 2015
Results First Posted Date  ICMJE March 17, 2015
Last Update Posted Date October 9, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
Electrophysiological Auditory Test [ Time Frame: Recordings were conducted during one session ]
auditory P300 amplitude in response to "rare" 1000 Hz tones
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Before and after measures of behavioral and electrophysiological auditory tests, and before and after functional magnetic resonance imaging results while auditory tests are administered [ Time Frame: For MS group, outcomes are measured at the completion of the four week auditory training program ]
Change History Complete list of historical versions of study NCT01023074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • Neural Magnetic Resonance Imaging (MRI) [ Time Frame: Results were recorded during one scanning session ]
    Gray matter volume
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Training on Central Auditory Function in Multiple Sclerosis
Official Title  ICMJE Effects of Training on Central Auditory Function in Multiple Sclerosis
Brief Summary The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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.
  • Other: MS: Control Activity
    MS group not receiving auditory training, doing control activity
Study Arms  ICMJE
  • No Intervention: Non-MS Control
    Non-MS control group
  • Active Comparator: MS: Auditory Training
    MS group receiving auditory training
    Intervention: Behavioral: Auditory training
  • Placebo Comparator: MS: Control Activity
    MS group not receiving auditory training, doing control activity
    Intervention: Other: MS: Control Activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2015)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
158
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023074
Other Study ID Numbers  ICMJE B4762-R
NCRAR-VA-04-1205 ( Other Identifier: Portland VA Medical Center IRB )
OHSU - 3188 ( Other Identifier: Oregon Health Sciences University IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Oregon Health and Science University
Investigators  ICMJE
Principal Investigator: Dennis N. Bourdette, MD VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP