Hyporeactivity and Gulf War Illness

NCT00100412 | Completed

• 1 other identifier: MHBS-001-99S1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is a follow-up to the prior VA-funded study that found that chronic fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular stress response regulation. Specifically, ill veterans had diminished autonomic responses during demanding psychosocial tasks involving high level cognitive processing and emotional stress. There was a close relationship between clinical status of ill veterans and their inability to mount an appropriate physiological response under stress. The main objective of the present investigation is to determine the specific mechanism through which this abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation to stressors involving higher brain activities. The second major focus of this study is to explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities in stress response regulation. This aspect of the study may also provide pertinent information as to the role of stress of military deployment as a contributing factor in post-Gulf War illnesses.

Conditions

Gulf War Syndrome; Chronic Fatigue Syndrome; Post-Traumatic Stress Disorder

Interventions

Graded dobutamine infusions DRUG

Graded phenylephrine injections DRUG

Psychosocial challenge involving socioevaluative public speaking BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* All former military personnel who participated in the Gulf War campaign and who meet the criteria for inclusion will be eligible to participate in the study. * Subjects with medical conditions that could explain their symptoms or with CDC-defined psychiatric exclusions (schizophrenia, mania, bulimia, and substance abuse disorders) will not participate in the study. * Other exclusions will be pregnancy, traumatic brain injury, or a history of any form of cardiovascular disease or related symptoms. * Other restrictions on participation will include any medication that impact on cardiovascular autonomic control, benzodiazepines, and antibiotics. * Subjects taking nonsteroidal anti-inflammatory/analgesic agents, mild short-acting hypnotics, and SSRIs will be accepted into the study, but will be requested to withdraw from their medications with the agreement and under the supervision of their physician. These subjects will be scheduled for the study after a washout period of 5 half-lives.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Gulf War Research Center

East Orange, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Persian Gulf Syndrome; Fatigue Syndrome, Chronic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 30, 2004
• First Posted: December 31, 2004
• Study Start: October 1, 1999
• Study Completion: September 1, 2002
• Last Updated: January 21, 2009

Record last verified: 2004-12

Locations

US (1)