A Magnetic Resonance Imaging (MRI) Study to Investigate Differences in the Structure and the Function of the Brain at Rest; Between Persons With Functional Pain Conditions Such as IBS or Vulvodynia, IBD and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Resting state networks
研究概览
简要总结
The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of Structural Neuroimaging is to use MRI technology to identify cortical and white matter morphometric differences between patients with chronic pain conditions and healthy control subjects.
The purpose of the Resting State Neuroimaging study is to use functional MRI to identify possible disease related differences in various resting state networks in the brain.
In addition we are looking at the effect gut microbiota on brain function in healthy and IBS participants.
The overall goal is to identify structural and functional brain differences in persons with chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between these conditions and matched healthy control subjects.
详细描述
The study involves 2 visits. The screening visit is about 90 minutes and involves signing the consent, completing questionnaires, a medical history, modified physical exam and psychological interview to identify stressors, anxiety, depression and other conditions.
The second visit is the MRI visit (both functional and structural) and also will take about 90 minutes, with the scanning lasting about 45 minutes. There are questionnaires and a measure of skin conductance also.
We have added a single stool sample for microbiota analysis and a food frequency questionnaire in the healthy control and IBS populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women who meet the following criteria are eligible for inclusion in the study:
- •18 to 55 years of age
- •ROME III criteria for IBS population
- •Willingness to participate in this study as evidenced by a signed, written informed consent form (ICF).
- •If female and of childbearing potential willingness to avoid pregnancy and practice adequate birth control (abstinence, oral contraception, intrauterine devices, implantable devices, depot contraceptives, or barrier method with spermicide) during the time of study enrollment.
- •If female, negative urine pregnancy tests at Screening Visit 1, and visit
- •Right handed
- •Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
- •English is primary oral and written language.
- •Diagnosed with CVS
- •Diagnosed with IBD and currently not taking steroid therapy.
- •Diagnosed with vestibulodynia (a subgroup of vulvodynia)
- •Pre and peri menopausal only, post menopausal excluded.
排除标准
- •Evidence of structural abnormality of the gastrointestinal tract. Subjects with Functional GI conditions must be without 'red flags', that may indicate gastrointestinal disease. Exclusionary GI conditions include but are not limited to: gastrointestinal surgery (exceptions: IBD group, appendectomy, benign polypectomy, cholecystectomy)also esophagitis, celiac disease, gastrointestinal malignancy or obstruction; peptic, duodenal or gastric ulcer disease.
- •Clinical evidence of cardiovascular, respiratory, renal, hepatic, malignancy, hematologic, neurologic, psychiatric or any disease that the PI determines may interfere with safe participation in the study
- •Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
- •Subjects with current regular use of narcotics and or opioids. Use of medications/drugs that affect the central nervous system. TCA's, SSRI's or other antidepressants are allowed if on stable dose for 3 months or more.
- •Pregnancy or breast feeding
- •Subjects with extreme obesity (BMI > 35%)
- •Subjects with metal implants, dental retainers, large tattoos (e.g. full arm or back) or claustrophobia; making MRI safety not possible.
结局指标
主要结局
Resting state networks
时间窗: within 1 week of scanning visit
The resting state functional MRI scan will be done to assess differences in the resting state networks in subjects with chronic pain conditions in comparison to healthy controls.
次要结局
未报告次要终点
研究者
Emeran Mayer, MD
Professor, Department of Medicine at the David Geffen School of Medicine, UCLA
University of California, Los Angeles