Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00262457 |
The purpose of this study is to determine the feasibility of an implanted electrical stimulation system incorporating BION microstimulators for long term use to prevent tissue breakdown in high risk patients.
Condition | Intervention |
---|---|
Pressure Ulcers Spinal Cord Injury |
Device: Implanted gluteal electrical stimulation system |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment |
Official Title: | BIONs, for Improved Tissue Health and Pressure Sore Prevention |
Enrollment: | 0 |
Study Start Date: | April 2004 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 | Device: Implanted gluteal electrical stimulation system |
The overall goal of this project is to implement the use of a gluteal stimulation system incorporating BION microstimulators for pressure ulcer prevention in patients at high risk of tissue breakdown as a standard clinical practice.The specific goal of this study is to establish the feasibility of a system incorporating BION microstimulators for long term use. This will be achieved by a two phase study. The initial phase of the study will employ biomechanical testing and in-vitro evaluations to address issues of safety and system design. The specific tasks to be achieved in the initial phase are:
Biomechanical testing to characterize the device response to traumatic loading conditions.
In-vitro testing to determine the optimal configuration of the system, specifically the effects of BION orientation and placement relative to the coil.
A series of cadaveric studies to determine guidelines for the BION implantation procedure required to achieve optimal function of the gluteal stimulation system.
The second phase of the study will be a pilot clinical trail of veterans with reduced mobility in order to establish clinical utility. A two-arm crossover study of wheelchair users will be carried out. A total of 10 subjects will be recruited to the study. Participants will be randomly assigned to Group A or Group B. All subjects will receive BION microstimulators implanted bilaterally adjacent to the motor point of the gluteus maximus. Two stimulation regimes will be employed; conditioning stimulation will be applied at night to increase muscle strength and fatigue resistance of the stimulated muscles while dynamic stimulation will be employed during the day in order to facilitate regular weight shifting, thus varying seated posture and pressure distributions at the seating interface. Subjects in Group A will start using dynamic and conditioning stimulation concurrently for 6 months following implantation. They will then cease using all stimulation for a further 6 months of participation in the study. Group B will not activate their stimulation systems for 6 months following implantation. They will then commence using dynamic and conditioning stimulation for 6 months.
All subjects will be followed for a 12 month period following implantation. Tissue health assessments will be carried out at three month intervals throughout their participation in the study. Progressive changes in gluteal tissue health will assessed by:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Department of Veterans Affairs ( Bogie, Kath - Principal Investigator ) |
Study ID Numbers: | B3259R |
Study First Received: | December 2, 2005 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00262457 |
Health Authority: | United States: Federal Government |
electrical stimulation Pressure Ulcers Spinal Cord Injury |
Spinal Cord Injuries Spinal Cord Diseases Skin Diseases Ulcer Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Skin Ulcer Pressure Ulcer |
Nervous System Diseases |