NCT00007722

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2000

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

October 9, 2009

Status Verified

October 1, 2009

Enrollment Period

2.7 years

First QC Date

December 29, 2000

Last Update Submit

October 7, 2009

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALSamyotrophic lateral sclerosisGulf War Veterans

Outcome Measures

Primary Outcomes (1)

  • Probability of ALS among veterans both deployed and non-deployed to the Gulf Region(8/2/1990-7/31/1991)

    Ongoing

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (3)

  • Horner RD, Grambow SC, Coffman CJ, Lindquist JH, Oddone EZ, Allen KD, Kasarskis EJ. Amyotrophic lateral sclerosis among 1991 Gulf War veterans: evidence for a time-limited outbreak. Neuroepidemiology. 2008;31(1):28-32. doi: 10.1159/000136648. Epub 2008 Jun 6.

    PMID: 18535397RESULT

  • Miranda ML, Alicia Overstreet Galeano M, Tassone E, Allen KD, Horner RD. Spatial analysis of the etiology of amyotrophic lateral sclerosis among 1991 Gulf War veterans. Neurotoxicology. 2008 Nov;29(6):964-70. doi: 10.1016/j.neuro.2008.05.005. Epub 2008 Jun 23.

    PMID: 18573277RESULT

  • Kasarskis EJ, Lindquist JH, Coffman CJ, Grambow SC, Feussner JR, Allen KD, Oddone EZ, Kamins KA, Horner RD; Als Gulf War Clinical Review Team. Clinical aspects of ALS in Gulf War veterans. Amyotroph Lateral Scler. 2009 Feb;10(1):35-41. doi: 10.1080/17482960802351029.

    PMID: 18792848RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eugene Z. Oddone, MD MHSc

    VA Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

December 29, 2000

First Posted

January 1, 2001

Study Start

July 1, 2000

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

October 9, 2009

Record last verified: 2009-10

Locations

US(1)