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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Auditory training; Other: MS: Control Activity

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrophysiological Auditory Test	auditory P300 amplitude in response to "rare" 1000 Hz tones	Recordings were conducted during one session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural Magnetic Resonance Imaging (MRI)	Gray matter volume	Results were recorded during one scanning session
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Dennis N. Bourdette, MD, VA Portland Health Care System, Portland, OR

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (ESTIMATE): December 2, 2009

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: MS; CAP
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: B4762-R; NCRAR-VA-04-1205 (OTHER: Portland VA Medical Center IRB); OHSU - 3188 (OTHER: Oregon Health Sciences University IRB)