BIONs, for Improved Tissue Health and Pressure Sore Prevention
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|ClinicalTrials.gov Identifier: NCT00262457|
Recruitment Status : Withdrawn (It was found that the devices were not suitable for the application.)
First Posted : December 6, 2005
Last Update Posted : September 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers Spinal Cord Injury||Device: Implanted gluteal electrical stimulation system||Not Applicable|
The overall goal of this project was 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:
- Transcutaneous oxygen measurement to measure tissue blood flow.
- Interface pressure measurement to determine pressure distribution changes over the long-term (due to muscle changes) and over the short-term (due to muscle contractions).
- Computerized tomography (CT) to measure muscle thickness. The results of this study will provide the pilot data for the development of a full-scale clinical trial of the gluteal BION system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||BIONs, for Improved Tissue Health and Pressure Sore Prevention|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Device: Implanted gluteal electrical stimulation system
Implanted electrical stimulation system incorporating BION microstimulators
- Improvement of tissue health [ Time Frame: Not feasible ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262457
|United States, Ohio|
|VA Medical Center, Cleveland|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Kath M. Bogie, PhD||VA Medical Center, Cleveland|