Viewing Study NCT00112333



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Study NCT ID: NCT00112333
Status: COMPLETED
Last Update Posted: 2011-07-20
First Post: 2005-06-01

Brief Title: Defining Central Circuits of Pain
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Defining Central Circuits of Visceral Pain
Status: COMPLETED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to use functional Magnetic Resonance Imaging MRI to help us understand what parts of the subjects 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
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 ROIs 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 grayPAG 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 eg pain and other hedonic ratings physiological monitoring such as heart rate etc with the changes in fMRI signal in specific areas of the brain

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None