Back to resultsFunctional Magnetic Micturition in Patients w/SCI
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Assistance in Voiding
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Bladder, electromagnetic fields, Spinal cord injury
Eligibility Criteria
Patients with SCI above T10 level, six months post injury
Sites / Locations
- VAMC, Long Beach
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00011557
First Posted
February 22, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00011557
Brief Title
Functional Magnetic Micturition in Patients w/SCI
Official Title
Functional Magnetic Micturition in Patients w/SCI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.
Detailed Description
Investigators intend to determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.
Thirty six persons will be recruited and will undergo an 8 week protocol for conditioning of the bladder. The investigators propose to: investigate the changes in bladder function in response to long-term bladder conditioning by FMS; further optimize the FMS technology and parameters for effective bladder emptying in SCI; evaluate the role of the external sphincter muscle fatigue by FS in facilitating bladder emptying; critically evaluate the relative response of FMS data to existing information using functional electrical stimulation;further develop criteria that will be used to predict which SCI patients are optimally suitable for FMS; establish a comprehensive stimulation criteria that will reflect the safety and effectiveness of structures associated with the bladder that are exposed to the electro-myographic field.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Bladder, electromagnetic fields, Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Assistance in Voiding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with SCI above T10 level, six months post injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fryer, Ph.D. Asst. Director
Organizational Affiliation
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Nancy Rocheleau, Program Analyst
Organizational Affiliation
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Facility Information:
Facility Name
VAMC, Long Beach
City
Long Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
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Functional Magnetic Micturition in Patients w/SCI
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