Defining Central Circuits of Pain
Primary Purpose
Dyspepsia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fMRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Dyspepsia focused on measuring Dyspepsia, fMRI
Eligibility 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
Sites / Locations
- Martinos Center for Biomedical Imaging
Outcomes
Primary Outcome Measures
Dyspepsia
Secondary Outcome Measures
Meal fullness
Full Information
NCT ID
NCT00112333
First Posted
June 1, 2005
Last Updated
July 19, 2011
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00112333
Brief Title
Defining Central Circuits of Pain
Official Title
Defining Central Circuits of Visceral Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Dyspepsia, fMRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
fMRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dyspepsia
Time Frame
after session
Secondary Outcome Measure Information:
Title
Meal fullness
Time Frame
after session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Braden Kuo, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martinos Center for Biomedical Imaging
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Defining Central Circuits of Pain
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