NCT00112333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2005

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

7.3 years

First QC Date

June 1, 2005

Last Update Submit

July 19, 2011

Conditions

Dyspepsia

Keywords

Dyspepsia, fMRI

Outcome Measures

Primary Outcomes (1)

  • Dyspepsia

    after session

Secondary Outcomes (1)

  • Meal fullness

    after session

Interventions

fMRIPROCEDURE

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.

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Braden Kuo, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2005

First Posted

June 2, 2005

Study Start

October 1, 2003

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)