Clinical Trial: Amyotrophic Lateral Sclerosis (ALS) Gulf War Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: CSP #500 - An Epidemiological Investigation Into the Occurrence of Amyotrophic Lateral Sclerosis (ALS) Among Gulf War Veterans

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.

Detailed Summary:

Primary Objectives: To develop, through nationwide ascertainment, a comprehensive descriptive epidemiology of amyotrophic lateral sclerosis (ALS) among Gulf War veterans with particular attention to whether there is a higher than expected occurrence of ALS among deployed veterans as compared to non-deployed Gulf War veterans.

Secondary Objectives: To ascertain probable/possible etiologic factors with particular focus on the role of chemical or biologic factors in the Persian Gulf area of deployment.

Primary Outcomes: Incidence of ALS among deployed and non-deployed veterans of the Gulf War.

Intervention: N/A

Study Abstract: 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). In response to this concern, a nationwide epidemiological investigation was conducted to ascertain all occurrences of ALS between August, 1990 and July, 2000 among all active duty military and mobilized Reserves, including National Guard, who served during the Gulf War period (August 2, 1990-July 31, 1991). A diagnosis of ALS was confirmed by medical record review and, as necessary, neurological examination. Risk was assessed by the age-adjusted, average, annual 10-year cumulative incidence rate. VA led this joint federal government epidemiologic study that also involved DoD, HHS, CDC, and academic centers of excellence in neurology, with advice from the ALS Association.

The study population was defined as all active duty military and mobilized reserves and National Guard
Sponsor: VA Office of Research and Development

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

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: VA Office of Research and Development

Dates:
Date Received: December 29, 2000
Date Started: July 2000
Date Completion:
Last Updated: October 7, 2009
Last Verified: October 2009