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NIH 海湾战争退伍军人健康调查性深度表型研究(NIH IN-DEPTH 项目)

Background:

Gulf War illness (GWI) affects up to 210,000 U.S. veterans who served in the Middle East during the Gulf War in 1990-1991. Symptoms include fatigue, muscle and joint pain, forgetfulness, headaches, rashes, and sleep disturbances. Routine exams cannot determine the cause of GWI. Researchers need more information to understand this disease.

Objective:

This natural history study will look for differences in Gulf War veterans who experienced GWI and those who did not.

Eligibility:

Gulf War veterans with GWI. Healthy Gulf War veterans who do not have GWI are also needed.

Design:

Participants will stay in the NIH Clinical Center as an inpatient for 2 weeks. They will undergo many tests.

Blood will be drawn many times throughout the study. Participants will also give urine, saliva, and stool samples.

Scans to measure the brain, leg muscles, bone density and body mass will be done.

They will have an exercise stress test and muscle strength tests.

They will have a sleep study. They will have tests to look at how well the brain, heart and lungs are working.

Participants will sleep in a specialized room that measures the amount of oxygen they use and the carbon dioxide they produce on four consecutive nights.

A sample of fluid will be collected from inside the spine.

Participants will take many surveys. Some will ask about their activities. Some will be about emotional and mental health. Some will be about thinking, memory, and behavior.

Optional tests include other imaging scans and testing the autonomic nervous system. Samples of skin and muscle may be taken.

After discharge, participants will wear activity monitors for 14 days. They will keep a diary of their symptoms, including fatigue, pain, and sleep, while wearing the monitors.

研究概览

地位

招聘中

详细说明

Study Description:

This protocol is part of a joint collaboration with the Veterans' Administration (VA) known as (Project IN-DEPTH). The Veterans' Administration protocol will recruit and identify participants for the NIH study, and maintain a repository of data and samples through a VA protocol (VA IN-DEPTH). The NIH protocol (NIH IN-DEPTH) will conduct deep phenotyping evaluations on study participants.

Gulf War Illness (GWI) and Gulf War Chronic Multi-Symptom Illness are names that have been used to describe a disorder of fatigue, muscle and joint pain, loss of concentration, forgetfulness, headache, respiratory complaints, rashes, sleep disturbances, and/or gastrointestinal distress. The purpose of this study is to learn more about GWI from veterans deployed in Persian Gulf during the first Gulf War.

In this study, two groups of veterans who were deployed to the Persian Gulf war between August 1990 and June 1991 will be enrolled: those who are healthy veteran controls (HVC) and those with GWI. Participants will have an inpatient study visit typically lasting 14 days to explore clinical and biological phenotypes through evaluations via questionnaires, medical procedures such as exercise testing, history and physical examination, and laboratory evaluation of samples.

This protocol is a "sister study" to the NIH protocol 16-N-0058: Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) at NIH. The symptoms of GWI and ME/CFS are very similar and much may be learned about each disorder through comparison. For this reason, the two studies will use similar methods. Participants in 16-N-0058 had previously consented to sharing of data, therefore datasets from this NIH IN-DEPTH protocol and 16-N-0058 will be shared and combined to perform several of the planned exploratory analyses.

This study will take place at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland.

Objectives: Primary Objective:

To explore and compare the clinical and biological phenotypes of veterans with GWI and healthy veteran controls (HVC) at baseline.

Exploratory Objectives:

To explore the pathophysiology of fatigue and GWI symptom flares. Fatigue will be explored using tasks designed to create muscular and cognitive fatigue. GWI symptom flares will be explored using an exercise stress test and measuring the symptomatic and biological changes.

To compare the clinical and biological phenotypes between GWI, HVC, ME/CFS, and healthy volunteers.

Endpoints: Outcome measures

The primary purpose of this protocol is to perform exploratory analysis of collected data and samples for the generation of new hypotheses regarding GWI. The types of analyses to be performed will be wide ranging. Planned areas of focus may include:

  • Characterization of the immune system and inflammatory signaling.
  • Characterization of the pattern of microbiome.
  • Characterization of bioenergetics, autonomic, and metabolic function.
  • Characterization of neurocognition.

研究类型

观察性的

注册 (估计的)

85

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • 招聘中
        • National Institutes of Health Clinical Center
        • 接触:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • 电话号码:TTY dial 711 800-411-1222
          • 邮箱:ccopr@nih.gov

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

48年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

A Target of 50 GWI participants and 25 Healthy volunteer controls will be selected.

描述

  • INCLUSION CRITERIA:

Inclusion criteria for all veterans:

  • Ability to provide informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age 48-70 at time of enrollment into VA IN-DEPTH Study
  • Veterans who were deployed to Gulf Region ODS/S between August 1990 - June 1991.
  • Self-reported completion of at least the seventh grade of school.
  • Fluency in speaking, reading, and understanding English.
  • Underwent screening as part of the VA IN-DEPTH study and were unanimously determined to be eligible by the IN-DEPTH Adjudication Committee.
  • Agree not to smoke in the 4 hours prior to CPET procedure

EXCLUSION CRITERIA:

Exclusion criteria for all veterans:

  • Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia
  • Current DSM-5-defined major depression disorder, generalized anxiety disorder, posttraumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen
  • Current or past substance use disorder within last five years as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5). Prior or prescription marijuana use within the past five years will not be an exclusion.
  • Current suicidal ideation
  • History of head injury leading to moderate or severe traumatic brain injury, as detailed by loss of consciousness for greater than 30 minutes, a Glasgow Coma Score of 12 or less at the time of injury, post-traumatic amnesia greater than one day, or brain-scan changes related to a head injury. Persons having a history of mild TBI (mTBI) will not be excluded.
  • Women who are pregnant, breastfeeding, or are within one-year post-partum.
  • Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.
  • Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed.
  • Current or previous long-term immune suppressive therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment
  • Any medical condition that would make the study procedures risky for the participant (e.g. congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, exercise-induced angina and poorly controlled asthma).
  • Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
  • Inability to perform the bicycling exercise task. (e.g. coronary artery disease, not having a lower limb, disabling stroke)
  • Not willing to allow for research data and samples to be shared broadly with other researchers.
  • Symptom severity that makes it impossible for the volunteer to travel to NIH for extended inpatient evaluation
  • Use of medications with a high-risk for withdrawal-related complications (i.e. long-acting opiates or benzodiazepines).

Additional Exclusion criteria for participants undergoing TMS:

- Pacemaker, implanted pump, stimulator, cochlear implant or metal objects inside the eye or skull.

Participants with unconfirmed metal may have further evaluation to rule out metal in the eye or skull.

Participants without metal after evaluation may proceed to TMS.

- A personal history of seizure disorder

Additional Exclusion criteria for participants undergoing MRI:

- Metal in the body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or having a history of being a welder or metal worker, since small metal fragments may be in the eye. Participants with unconfirmed metal may have further evaluation to rule out metal in the eye

or skull. Participants without metal after evaluation may proceed to MRI.

  • Substantial claustrophobia
  • Inability to lie on back for up to 2 hours

Additional Exclusion criteria for Healthy Veteran Controls:

- Meets modified Kansas criteria for GWI.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
GWI

Gulf War Veterans

HVC

Healthy Volunteer Controls

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To explore and compare the clinical and biological phenotypes of veterans with GWI and healthy veteran controls (HVC) at baseline.
大体时间:one time visit

Evaluate a number of clinical and biological measures.

one time visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Brian T Walitt, M.D.、National Institute of Neurological Disorders and Stroke (NINDS)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年4月16日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2022年5月13日

首先提交符合 QC 标准的

2022年5月16日

首次发布 (实际的)

2022年5月17日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月31日

最后验证

2026年10月30日

更多信息

与本研究相关的术语

其他研究编号

  • 10000051
  • 000051-N

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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