NCT00037947

Brief Summary

We propose to evaluate auditory function and neuropsychologic function in 150 Multiple Sclerosis (MS) patients and in 150 patients who do not have MS. Experimental subjects will be recruited by selecting patients with a verified diagnosis of MS from the registry of patients established by the Oregon Health Sciences University, Multiple Sclerosis Research Center. Control subjects will be matched with respect to age, to gender and to audiometric configuration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

6.2 years

First QC Date

May 24, 2002

Last Update Submit

June 2, 2008

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMSHearing

Interventions

Hearing in Multiple SclerosisPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Multiple Sclerosis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Portland, Oregon, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Hearing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Wolff, Ph.D. Special Assistant to the Director

    Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service

  • Danielle Kerkovitch, Ph.D.

    Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

October 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

US(1)