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BIONs, for Improved Tissue Health and Pressure Sore Prevention

This study has been withdrawn prior to enrollment.
(It was found that the devices were not suitable for the application.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00262457
First received: December 2, 2005
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

The purpose of this study was 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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BIONs, for Improved Tissue Health and Pressure Sore Prevention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Improvement of tissue health [ Time Frame: Not feasible ] [ Designated as safety issue: No ]

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
Arm 1
None
Device: Implanted gluteal electrical stimulation system
Implanted electrical stimulation system incorporating BION microstimulators

Detailed Description:

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:

  1. Transcutaneous oxygen measurement to measure tissue blood flow.
  2. 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).
  3. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Motor and sensory complete spinal cord injury above the level T12.
  • No open skin problems or hospitalizations during the three months prior to entrance into the study.

Exclusion Criteria:

  • Age less than 18 years.
  • Less than two years post-injury or loss of independent walking ability.
  • More than three urinary tract infections in the previous year.
  • Significant active systemic disease, e.g. heart disease, renal failure, diabetes.
  • Abnormal nutritional status based on albumin and total protein levels at recruitment (3.0 for albumin, 6.0 for total protein).
  • Osteomyelitis of the pelvic region, indicated by positive pelvic inlet X-ray from routine annual urologic examination or bone scan.
  • Previous surgery in the perineal region that radically alters the basic anatomy, particularly regional innervation and blood supply, e.g. amputation, hemipelvectomy.
  • Extensive lower motor neuron damage to motor nerves innervating the gluteal muscles or electrical excitability of gluteal muscles with lower motor neuron innervation insufficient to produce desired level of contraction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262457

Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Kath M. Bogie, PhD VA Medical Center, Cleveland
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00262457     History of Changes
Other Study ID Numbers: B3259-R
Study First Received: December 2, 2005
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
electrical stimulation
Pressure Ulcers
Spinal Cord Injury

Additional relevant MeSH terms:
Pressure Ulcer
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Skin Diseases
Skin Ulcer
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014