Effects of Training on Central Auditory Function in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effects of Training on Central Auditory Function in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023074
• Other study ID #: B4762-R
• Secondary ID: NCRAR-VA-04-1205
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: June 2011

Study information

• Verified date: September 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrophysiological Auditory Test	auditory P300 amplitude in response to "rare" 1000 Hz tones	Recordings were conducted during one session
Secondary	Neural Magnetic Resonance Imaging (MRI)	Gray matter volume	Results were recorded during one scanning session
Secondary	SCAN-A: Competing Words Test	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.	Test administered during one session