Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest.
| Status: | Completed |
|---|---|
| Conditions: | Angina, Colitis, Gastroesophageal Reflux Disease , Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | July 2015 |
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
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.
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.
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.
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.
Inclusion Criteria:
Men and women who meet the following criteria are eligible for inclusion in the study:
1. 18 to 55 years of age
2. ROME III criteria for IBS population
3. Willingness to participate in this study as evidenced by a signed, written informed
consent form (ICF).
4. 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.
5. If female, negative urine pregnancy tests at Screening Visit 1, and visit 2.
6. Right handed
7. Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
8. English is primary oral and written language.
9. Diagnosed with CVS
10. Diagnosed with IBD and currently not taking steroid therapy.
11. Diagnosed with vestibulodynia (a subgroup of vulvodynia)
12. Pre and peri menopausal only, post menopausal excluded.
Exclusion Criteria:
1. 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.
2. 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
3. Use of investigational drugs, products or devices within 28 days prior to screen and
through study participation.
4. 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.
5. Pregnancy or breast feeding
6. Subjects with extreme obesity (BMI > 35%)
7. Subjects with metal implants, dental retainers, large tattoos (e.g. full arm or back)
or claustrophobia; making MRI safety not possible.
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