Defining Central Circuits of Pain

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00112333
First received: June 1, 2005
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

The purpose of the study is to use functional Magnetic Resonance Imaging (MRI) to help us understand what parts of the subject's brain are involved when he experiences visceral pain, or pain in the gut. To stimulate the brain, he will be infused with a liquid meal (Ensure) into his stomach until he is maximally full. Magnetic resonance imaging (MRI) is a technique for making images (pictures) of the brain; it uses magnetic fields and radio waves and is not harmful. This study uses a new investigational technique called functional MRI (fMRI), which is a very fast MRI technique that will allow the investigators to evaluate changes in how blood flows to parts of his brain.


Condition Intervention
Dyspepsia
Procedure: fMRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Defining Central Circuits of Visceral Pain

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Dyspepsia [ Time Frame: after session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Meal fullness [ Time Frame: after session ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2003
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: fMRI
    A liquid meal (Ensure 1Kcal/cc) will be infused into the stomach via a nasogastric tube at a rate of 60cc/min till the subject reaches maximal satiety. The amount of liquid meal will differ per subject.
Detailed Description:

Dyspepsia, a condition characterized by upper abdominal discomfort, is one of the most common types of pains in clinical practice and is one of the most common reasons for visits to primary care physicians and gastroenterologists. But relative to somatic pain, little fundamental information is known about visceral pain syndromes such as dyspepsia and irritable bowel syndrome. Recent exciting advances in neuroimaging such as functional magnetic resonance imaging (fMRI) have allowed investigators to interrogate neural signal changes in humans in a wide variety of pain conditions. But to date neuroimaging has not provided details of activation in specific neural circuits that are important in visceral pain. In these experiments we will focus on specific regions of interest (ROI's) that have shown to be relevant in animal models of pain circuitry including the dorsal column nuclei, the thalamus, the hypothalamus, the amygdala and the periaqueductal gray.

The specific aims of our proposed project are:

  1. To measure fMRI signal in primary visceral afferent pain pathways (dorsal column nuclei and thalamus) in normal human subjects and in patients with dyspepsia following instilling a liquid meal at a fixed rate into the stomach until maximal satiety, a surrogate model of dyspepsia.
  2. To measure fMRI signal in autonomic pathways (hypothalamus and amygdala) and in endogenous analgesic pathways (periaqueductal gray/PAG) in normal human subjects and in patients with dyspepsia using the above model.
  3. To correlate physiological parameters (heart rate, skin conductance, respiratory rate) to hedonic ratings (ratings on a visual analogue scale of satiety, nausea, bloating, and pain) during the liquid meal stimulus in normal human subjects and patients with dyspepsia.

In all these experiments we will correlate alterations in psychophysical measures which have traditional measures of pain response (e.g., pain and other hedonic ratings, physiological monitoring such as heart rate, etc) with the changes in fMRI signal in specific areas of the brain.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right handed men and non-pregnant women ages 18 to 64

Exclusion Criteria:

  • Diabetes
  • History of aspiration or severe respiratory complications linked to gastrointestinal disease
  • Use of any over the counter medications within 7 days of the study
  • Current or previous history of gastric surgery
  • Use of any medications which may alter gastrointestinal motility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112333

Locations
United States, Massachusetts
Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Braden Kuo, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Braden Kuo, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00112333     History of Changes
Other Study ID Numbers: 2003-P-001304
Study First Received: June 1, 2005
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Dyspepsia, fMRI

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014