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Effects of Training on Central Auditory Function in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Auditory training

MS: Control Activity

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring MS, CAP

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Placebo Comparator

Arm Label

Non-MS Control

MS: Auditory Training

MS: Control Activity

Arm Description

Non-MS control group

MS group receiving auditory training

MS group not receiving auditory training, doing control activity

Outcomes

Primary Outcome Measures

Electrophysiological Auditory Test

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

Secondary Outcome Measures

Neural Magnetic Resonance Imaging (MRI)

Gray matter volume

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.

Full Information

NCT ID

NCT01023074

First Posted

November 30, 2009

Last Updated

September 10, 2018

Sponsor

VA Office of Research and Development

Collaborators

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01023074

Brief Title

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

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

MS, CAP

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-MS Control

Arm Type

No Intervention

Arm Description

Non-MS control group

Arm Title

MS: Auditory Training

Arm Type

Active Comparator

Arm Description

MS group receiving auditory training

Arm Title

MS: Control Activity

Arm Type

Placebo Comparator

Arm Description

MS group not receiving auditory training, doing control activity

Intervention Type

Behavioral

Intervention Name(s)

Auditory training

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

MS: Control Activity

Intervention Description

MS group not receiving auditory training, doing control activity

Primary Outcome Measure Information:

Title

Electrophysiological Auditory Test

Description

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

Time Frame

Recordings were conducted during one session

Secondary Outcome Measure Information:

Title

Neural Magnetic Resonance Imaging (MRI)

Description

Gray matter volume

Time Frame

Results were recorded during one scanning session

Title

SCAN-A: Competing Words Test

Description

Time Frame

Test administered during one session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis N. Bourdette, MD

Organizational Affiliation

VA Portland Health Care System, Portland, OR

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Portland Health Care System, Portland, OR

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

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Effects of Training on Central Auditory Function in Multiple Sclerosis

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