Is there a higher than expected occurrence of ALS among deployed veterans as compared to non-deployed Gulf War veterans?

This study is currently recruiting patients.

Sponsored by

Department of Veterans Affairs
Department of Veterans Affairs Cooperative Studies Program Department of Defense
Centers for Disease Control and Prevention Department of Health and Human Services
ALS Association

Purpose

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
Amyotrophic Lateral Sclerosis


MEDLINEplusrelated topics:AmyotrophicLateralSclerosis

Study Type:Observational
Study Design:Natural History

Official Title:An Epidemiological Investigation into the Occurrence of Amyotrophic Lateral Sclerosis (ALS) Among Gulf War Veterans

Further Study Details:


Primary Objectives: To develop, through nationwide ascertainment, a comprensive 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). 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.

This study is the first phase of a two-phased 3-year investigation into the occurrence and epidemiology of ALS among Gulf War veterans. This phase, occurring over a one year period, involves complete ascertainment and comprehensive evaluation of ALS cases among veterans of the Gulf War. The major objective is to estimate the incidence of ALS among deployed and non-deployed Gulf War veterans and to compare these rates to each other and to those of non-veteran populations as reported in the literature. We also will create a system for continued surveillance of new cases among Gulf War veterans. The population of interest is comprised of individuals who were active duty military for one month or more during the period 8/2/90 to 7/31/91. Deployed veterans are defined as those who were sent to the Persian Gulf during that period; non-deployed are those who remained in U.S. or were deployed to areas other than the Persian Gulf during the study period.

This study has as its primary component a field epidemiological investigation, involving nationwide ascertainment of ALS cases among deployed and non-deployed veterans of the Gulf War to obtain a census of ALS cases among these populations. Ascertainment of cases is through three avenues. The first is a search of extant VA and DoD medical databases. Second, we are soliciting cases from the ALS Association, other related organizations, and from VA and DoD neurology clinics. And third, we are identifying cases through self-referrals that result from national media announcements. Purported cases are being verified via medical record review and, as necessary, a detailed clinical examination. For all living cases, we will collect a sample of blood and urine for determination of ALS-relevant DNA mutations and heavy metal exposure, respectively. There also will be an in-home visit that will include an interview of the patient and family members with emphasis on ascertainment of unique exposures. The data arising from this effort will be used to ascertain whether there is a higher than expected occurrence of ALS among the deployed veterans vis-a-vis non-deployed Gulf War veterans and general U.S. populations.

To-date, 41 subjects have been enrolled in the study; 32 of those subjects have a suspected or confirmed diagnosis of ALS. Case ascertainment efforts continue and the medical record review process to confirm ALS disease status is underway for enrolled subjects.

The results of this study have importance for VA in achieving its mission to provide for the health of veterans and for the larger U.S. society in understanding ALS. From the VA perspective, this project will indicate whether veterans deployed to the Persian Gulf during the Gulf War are at elevated risk of ALS. If so, strategies can be designed for prompt identification and appropriate clinical management of ALS patients in this population. From the broader perspective, a study of ALS in relatively young individuals may provide knowledge regarding the epidemiology, and particularly, the etiology of this disease.


Eligibility

Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both

Participants: Patients

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)


Location and Contact Information

North Carolina
VAMC - DURHAM, NC,Durham, North Carolina, 27705, United States;Recruiting

Ronnie D. Horner, PhD 919-286-6936 horne003@mc.duke.edu

More Information

Study ID Numbers 500
NLM Identifier NCT00007722

Date study startedMarch 2000; Date Study Completed July 2001 Record last reviewed December 2000