Clinical trial NCT01023074: Effects of Training on Central Auditory Function in Multiple Sclerosis
Official title: Effects of Training on Central Auditory Function in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: MS
CAP
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2009-12-02
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Electrophysiological Auditory Test
timeFrame: Recordings were conducted during one session
Secondary outcomes:
measure: Neural Magnetic Resonance Imaging (MRI)
timeFrame: Results were recorded during one scanning session
measure: SCAN-A: Competing Words Test
timeFrame: Test administered during one session
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Dennis N. Bourdette, MD
role: PRINCIPAL_INVESTIGATOR
References: