ClinicalTrials.gg
CompletedNCT00112333Updated Jul 20, 2011

Defining Central Circuits of Pain

An interventional study of fMRI in Dyspepsia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-20.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyspepsia

Browse trials for

Keywords

  • Dyspepsia, fMRI
03

In context

Dyspepsia

370 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's planned enrollment of 60 is below the median of 87 across 303 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • ProcedurefMRI

    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.

06

What researchers measure

Primary outcomes

  1. Dyspepsia

    Time frame: after session

Secondary outcomes

  1. Meal fullness

    Time frame: after session

07

Study locations

1 site
  • Martinos Center for Biomedical Imaging
    Charlestown, Massachusetts 02129, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00112333
First posted
Jun 2, 2005
Start date
Oct 2003
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Jul 20, 2011

Study contacts

Braden Kuo, M.D.
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion