NCT01023074

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

October 9, 2018

Status Verified

September 1, 2018

Enrollment Period

3.7 years

First QC Date

November 30, 2009

Results QC Date

January 29, 2015

Last Update Submit

September 10, 2018

Conditions

Multiple Sclerosis

Keywords

MSCAP

Outcome Measures

Primary Outcomes (1)

  • Electrophysiological Auditory Test

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

    Recordings were conducted during one session

Secondary Outcomes (2)

  • Neural Magnetic Resonance Imaging (MRI)

    Results were recorded during one scanning session

  • SCAN-A: Competing Words Test

    Test administered during one session

Study Arms (3)

Non-MS Control

NO INTERVENTION

Non-MS control group

MS: Auditory Training

ACTIVE COMPARATOR

MS group receiving auditory training

Behavioral: Auditory training

MS: Control Activity

PLACEBO COMPARATOR

MS group not receiving auditory training, doing control activity

Other: MS: Control Activity

Interventions

Auditory trainingBEHAVIORAL

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

MS: Auditory Training
MS: Control ActivityOTHER

MS group not receiving auditory training, doing control activity

MS: Control Activity

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Robert Folmer, Ph.D.
Organization
Portland VA Medical Center
Robert.Folmer@va.gov
503-220-8262

Study Officials

  • Dennis N. Bourdette, MD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

October 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 9, 2018

Results First Posted

March 17, 2015

Record last verified: 2018-09

Locations

US(1)