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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00011557 |
Purpose
This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Device: Assistance in Voiding |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Functional Magnetic Micturition in Patients w/SCI |
| Estimated Enrollment: | 36 |
| Study Start Date: | January 1998 |
| Study Completion Date: | December 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients with SCI above T10 level, six months post injury
Contacts and Locations| United States, California | |
| VAMC, Long Beach | |
| Long Beach, California, United States | |
| Investigator: | John Fryer, Ph.D. Asst. Director | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service |
| Investigator: | Nancy Rocheleau, Program Analyst | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service |
More Information
| Study ID Numbers: | B1747R |
| Study First Received: | February 22, 2001 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00011557 History of Changes |
| Health Authority: | United States: Federal Government |
|
Bladder, electromagnetic fields, Spinal cord injury |
|
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
|
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |