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Amyotrophic Lateral Sclerosis (ALS) Gulf War Study

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ClinicalTrials.gov Identifier: NCT00007722
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : October 9, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Recently, concern has arisen regarding a possible elevated occurrence of ALS among veterans who served in the Persian Gulf during Operations Desert Shield (August 2, 1990 - January 15, 1991), Desert Storm (January 16, 1991 - February 28, 1991) and Clean-up (March 1, 1991 - July 31, 1991). This study involves an epidemiologic investigation into the occurrence of ALS among veterans of the Gulf War. This study will further define the epidemiology of this neurological disease among younger individuals while determining whether there is a higher than expected occurrence. It will also ascertain the etiologic importance of deployment to the Persian Gulf and exposure to specific environmental factors in that geographic area. VA is leading this joint federal government epidemiologic study that also involves DoD, HHS, CDC, and academic centers of excellence in neurology, with advice from the ALS Association.

Condition or disease
Amyotrophic Lateral Sclerosis

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CSP #500 - An Epidemiological Investigation Into the Occurrence of Amyotrophic Lateral Sclerosis (ALS) Among Gulf War Veterans
Study Start Date : July 2000
Primary Completion Date : March 2003
Study Completion Date : March 2003


Groups and Cohorts

Group/Cohort
1


Outcome Measures

Primary Outcome Measures :
  1. Probability of ALS among veterans both deployed and non-deployed to the Gulf Region(8/2/1990-7/31/1991) [ Time Frame: Ongoing ]

Biospecimen Retention:   Samples With DNA
DNA samples of blood or mouthwash were collected in veterans' homes by nurses.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Living and deceased veterans with an ALS diagnosis who served in the military between 8/2/1990 and 7/31/1991.
Criteria

Inclusion Criteria:

Veterans who served in the Persian Gulf during Operations Desert Shield (August 2, 1990 - January 15, 1991), Desert Storm (January 16, 1991 - February 28, 1991) and Clean-up (March 1, 1991 - July 31, 1991)

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007722


Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
United States Department of Defense
Centers for Disease Control and Prevention
Department of Health and Human Services
ALS Association
Investigators
Study Chair: Eugene Z. Oddone, MD MHSc VA Office of Research and Development
More Information

Publications:
Responsible Party: Oddone, Eugene - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007722     History of Changes
Other Study ID Numbers: 500
First Posted: January 1, 2001    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 2009

Keywords provided by VA Office of Research and Development:
ALS
amyotrophic lateral sclerosis
Gulf War Veterans

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases