Back to resultsEffects of Acute SCI on Colonic Motility & Tone
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Determine colonic tone
Sponsored by
About this trial
This is an interventional diagnostic trial for Spinal Cord Injury focused on measuring Spinal cord injury, gastrointestinal motility, gastrointestinal transit
Eligibility Criteria
Acute SCI with impaired colonic tone
Sites / Locations
- VAMC, Hines
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013312
First Posted
March 14, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013312
Brief Title
Effects of Acute SCI on Colonic Motility & Tone
Official Title
Effects of Acute SCI on Colonic Motility & Tone
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal cord injury, gastrointestinal motility, gastrointestinal transit
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Determine colonic tone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Acute SCI with impaired colonic tone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fryer, Ph.D. Asst. Director
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Nancy Rocheleau, Program Analyst
Organizational Affiliation
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Facility Information:
Facility Name
VAMC, Hines
City
Hines
State/Province
Illinois
Country
United States
12. IPD Sharing Statement
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Effects of Acute SCI on Colonic Motility & Tone
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