Neuroimaging and Biomarkers in Chronic Visceral Pain
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Visceral Pain
Study type: Interventional

Summary: 
      The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate
      brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training
      on these measures. The goal of this study is to identify biomarkers of IBS and assess the
      responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is in
      general a substance or measure used as an indicator of a biological state. It is a
      characteristic that is measured and evaluated as an indicator of normal biological processes,
      disease processes, or responses to a therapeutic intervention, in this case MBSR.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is the most common chronic visceral pain disorder ranking
      among the most common of all persistent pain disorders with prevalence rates of 8-12% of the
      population.3 Diagnostic criteria for IBS include persistent abdominal pain and/or discomfort
      associated with changes in bowel habit. In the majority of patients, symptoms of other
      co-morbid pain conditions, such as epigastric pain (functional dyspepsia), pelvic pain
      (IC/PBS) and musculoskeletal pain (FM) are reported. Estimates are that >50% of the U.S.
      workforce experiences some type of pain and 13% lose productive work time due to pain over a
      2 week period, leading to over 60 billion dollars per year in lost productivity costs.4 There
      are no generally agreed upon biomarkers for IBS, and diagnoses are exclusively based on
      subjective symptom criteria. As with most of the persistent pain disorders, IBS patients and
      their providers have increasingly embraced a biopsychosocial model incorporating
      psychological and social factors along with physiologic factors, and this forms the basis for
      integrative treatment approaches. This multimodal approach often incorporates Mind-Body
      treatments, and there is a growing literature showing clinical efficacy in IBS for
      interventions incorporating such Mind-Body approaches as meditation, hypnosis, yoga and
      cognitive therapy.5 However, there is little understanding of the physiological mechanisms
      underlying mind-body therapies, and for this reason optimization of the treatments for
      specific individuals and populations is difficult.

      In this project we aim to use neuroimaging based biomarkers of IBS to examine which of these
      physiological measures show changes specific to a mind-body treatment with previously
      documented efficacy, Mindfulness Based Stress Reduction Training or MBSR. MBSR was chosen as
      a target treatment for several reasons: Recent clinical trial data suggests there is efficacy
      in improving IBS symptoms with MBSR, it has demonstrated prior success with other chronic
      pain conditions and there is considerable literature on meditation associated brain changes.

      The primary Objective is to validate optimal biomarker candidates by assessment of treatment
      responsiveness in IBS patients following Mindfulness Based Stress Reduction (MBSR). The
      secondary objectives are to determine the generality of optimal biomarkers from Aim 1 and 2
      and look at factors such as sex, age, co-morbid pain or mood symptoms, and/or baseline
      disease severity as moderators of the performance of candidate biomarkers.

      Also, exploratory analyses will be performed to assess the effect of an 8 week MBSR training
      on measures of disease cognition, quality of life and mood defined by pre and post test
      scores on the behavioral measures listed in the study methods.
    

Intervention name(s): Mindfulness based Stress Reduction Training (MBSR)
Intervention type(s): Behavioral
Intervention description(s): 8 (2 hr) classes weekly of MBSR and required homework of MBSR practice approximately 30 minutes per day.
Other intervention name(s): Spastic colon; Irritable colon; MBSR; Mindfulness Meditation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS, FMRI, MBSR