Neuroimaging and Biomarkers in Chronic Visceral Pain

NCT01602575 | Completed DMC

• 1 other identifier: R01AT007137
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS, FMRI, MBSR

Outcome Measures

Primary Outcomes (1)

• Validate Optimal Biomarker candidates

  To validate optimal brain biomarker candidates by assessment of treatment responsiveness in IBS patients following and 8 week course in Mindfulness Based Stress Reduction (MBSR).

  After MBSR training (8 weeks).

Secondary Outcomes (1)

• Specificity, generality and moderation of biomarker response to MBSR treatment.

  Post MBSR training at 3 month follow up.

Study Arms (1)

mindfulness treatment

EXPERIMENTAL

Mindfulness based stress reduction is the intervention in this single arm trial

Behavioral: Mindfulness based Stress Reduction Training (MBSR)

Interventions

Mindfulness based Stress Reduction Training (MBSR) BEHAVIORAL

8 (2 hr) classes weekly of MBSR and required homework of MBSR practice approximately 30 minutes per day.

Also known as: Spastic colon, Irritable colon, MBSR, Mindfulness Meditation

mindfulness treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must meet the Rome III criteria for IBS and lack red flag symptoms, such as weight loss, bloody stool, and fever. In the setting of clinical uncertainty on the part of the examining gastroenterologist, laboratory testing or prior medical records may be requested.
• Upper gastrointestinal symptoms, ie. dyspepsia or heartburn, are acceptable as long as IBS is their most bothersome symptom complex.
• Subject cannot have completed structured training in MBSR or other mindfulness or meditation.
• Subject cannot be currently practicing MBSR.
• A minimal severity score of 75 on the IBS-SSS at screening will be required to ensure at least mild-moderate symptoms at baseline.
• Literate in English
• Ambulatory without a need for assistive devices.
• Able to participate in the sitting and mild yoga positions required for the MBSR course.
• Right handed due to importance of laterality in brain imaging analysis
• Not pregnant, nursing or postpartum.
• No metals in body, including ferrous metallic implants and tattoos
• No history of claustrophobia.
• Able to lay still on back for extended period of time ( about 90 minutes).
• if unable to participate in the MRI portion of the study you may be eligible to come to the MBSR classes at no cost if you agree to complete the classes, homework and on-line questionnaires.

You may not qualify if:

• Planned major medical intervention in the next 6 months (e.g. surgery), or surgery in the past 6 months.
• Presence of a significant and ongoing medical problem that would interfere with participation in the study or testing the study hypotheses (e.g. major heart disease, neurological disorders, inflammatory bowel disease, etc).
• Presence of a major psychiatric diagnosis such as schizophrenia, Bipolar disorder, Post-traumatic Stress Disorder, or Obsessive Compulsive disorder. However, subjects with a history of DSMIV diagnosis of Anxiety or Depression, in whom symptoms are not active will be allowed but noted for post-hoc analysis.
• use of centrally acting medications that will interfere with the neuroimaging testing (e.g. narcotic medications). As in past studies we will allow subjects taking stable doses of antidepressant medications (TCAs, SSRIs, SNRIs) for at least six months prior to study to participate.
• Body Mass Index greater than 30.
• Current or past history of chronic pain syndrome other than IBS in the IBS group (pain \>6 months at any location).
• History of gastrointestinal surgery other than uncomplicated appendectomy or cholecystectomy.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oppenheimer Center for Neurobiology of Stress

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Ichthyosis Bullosa of Siemens

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kirsten Tillisch, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: January 1, 2013
• Primary Completion: March 20, 2016
• Study Completion: March 20, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)