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Completed

NCT Number: NCT01023074

Effects of Training on Central Auditory Function in Multiple Sclerosis

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

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory Training

Behavioral

the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS: Control Activity

Other

MS group not receiving auditory training, doing control activity

Primary outcomes

  1. Electrophysiological Auditory Test

    Time frame: Recordings were conducted during one session

    auditory P300 amplitude in response to "rare" 1000 Hz tones

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Oregon Health and Science University

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2009
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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