Amyotrophic Lateral Sclerosis (ALS) Gulf War Study

This study has been completed.
Sponsor:
Collaborators:
ALS Association
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007722
First received: December 29, 2000
Last updated: October 7, 2009
Last verified: October 2009
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Probability of ALS among veterans both deployed and non-deployed to the Gulf Region(8/2/1990-7/31/1991) [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA samples of blood or mouthwash were collected in veterans' homes by nurses.


Enrollment: 135
Study Start Date: July 2000
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007722

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
ALS Association
Investigators
Study Chair: Eugene Z. Oddone, MD MHSc Department of Veterans Affairs
  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
Study First Received: December 29, 2000
Last Updated: October 7, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
ALS
amyotrophic lateral sclerosis
Gulf War Veterans

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

ClinicalTrials.gov processed this record on August 01, 2014