Pressure UlcersNCT00623948
Implanted Gluteal Stimulation System for Pressure Sore Prevention
A study testing A fully implanted gluteal stimulation (GSTIM) system in people with Pressure Ulcers, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This project will evaluate the feasibility of using a fully implanted gluteal stimulation system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot clinical trial of veterans with reduced mobility in order to establish clinical efficacy of a 2-channel bilateral gluteal stimulation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- A fully implanted gluteal stimulation (GSTIM) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor and sensory complete SCI higher than the level T12.
Who cannot join
- Eligible subjects will have had no open skin problems or hospitalizations during the three months prior to entrance into the study. Additional exclusion criteria relating to clinical factors and suitability include:
- 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, compromised renal function, 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 regional, 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
This project will evaluate the feasibility of using a fully implanted gluteal stimulation system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot clinical trial of veterans with reduced mobility in order to establish clinical efficacy of a 2-channel bilateral gluteal stimulation system. A two-arm crossover study of wheelchair users with complete SCI will be carried out. All study participants will receive a fully implanted system incorporating implanted IM electrodes and a Micropulse I IPG stimulator (NDI Medical). Group assignments will be determined at enrollment using a modified randomization scheme. A total of 10 subjects will be recruited to the pilot clinical trial.
Read the detailed description
Within the scope of the study the aims will be to: (1. Develop the pre-implantation assessment protocol utilizing targeted CT to locate optimal gluteal motor points bilaterally.) CT assessment of the pelvic region in spinal cord injured subjects will be carried out to determine regional vascular and nervous anatomy. This will allow us to achieve optimal electrode placement using a minimally invasive implantation procedure. (2. Develop the implanted gluteal stimulation system.) The fully implanted gluteal stimulation (GSTIM) system is envisioned as a marriage between the established technology of the implanted IM electrodes developed by the Cleveland FES Center and the newly developed Micropulse I 2-channel stimulator. The Micropulse I IPG is a small, rechargeable stimulator developed by NDI Medical as a platform technology for neuromodulation and neurostimulation applications. The device will be customized in order to provide two synchronized channels of stimulation for the GSTIM system. (3. Implement and evaluate implanted gluteal stimulation system in human volunteers.) A pilot clinical trial of the fully implanted gluteal stimulation system will be carried out using a two-arm crossover study of ten wheelchair users at risk for pressure ulcer development due to impaired mobility. Pre-defined selection criteria will be employed to screen potential participants physically and psychologically. All participants will receive a stimulation system consisting of implanted IM electrodes inserted bilaterally in the gluteus maximus together with the Micropulse I stimulator implanted subcutaneously in the lower abdomen. Tissue health will be assessed at three month intervals during the 12-month period following implantation. The clinical application of this system is of great relevance to the veteran population at risk of pressure ulcer development. The project will add value to the continued improvement in health care provision for veterans, allowing them to benefit from the most recent advances in medical device technology. Although the initial target user group is veterans with SCI, the proposes system will have applications to other patient populations at risk due to reduced mobility, such as those with multiple sclerosis and the elderly.
- Conditions
- Pressure Ulcers
- Being tested
- A fully implanted gluteal stimulation (GSTIM) system
- Keywords
- Pressure ulcers, Electrical Stimulation, Spinal Cord Injury
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A fully implanted gluteal stimulation (GSTIM) systemDevice
A fully implanted gluteal stimulation system
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Device: A fully implanted gluteal stimulation (GSTIM) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes measures will be changes in tissue health variables and user satisfaction
Measured: baseline, 4 weeks, and six months
Secondary outcomes (2)
Progressive changes in muscle bulk and tissue blood flow will be evaluated using CT scanning and transcutaneous oxygen measurement
Measured: baseline, 4 weeks, and six months
Pressure distribution changes over the long-term (due to muscle changes) and over the short-term (due to muscle contractions) will be assessed by interface pressure measurement.
Measured: baseline, 4 weeks, and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startSep 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Suitable implanted technolgy was not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kath M. Bogie, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623948
- Sponsor's protocol ID
- B4664-R
- Status last verified
- May 2015
- First submitted
- 11 Feb 2008
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implanted Gluteal Stimulation System for Pressure Sore Prevention
- ClinicalTrials.gov ID
- NCT00623948
- Acronym / sponsor ID
- B4664-R
- Conditions
- Pressure Ulcers
- Keywords
- Pressure ulcers, Electrical Stimulation, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Suitable implanted technolgy was not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will evaluate the feasibility of using a fully implanted gluteal stimulation system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot clinical trial of veterans with reduced mobility in order to establish clinical efficacy of a 2-channel bilateral gluteal stimulation system. A two-arm crossover study of wheelchair users with complete SCI will be carried out. All study participants will receive a fully implanted system incorporating implanted IM electrodes and a Micropulse I IPG stimulator (NDI Medical). Group assignments will be determined at enrollment using a modified randomization scheme. A total of 10 subjects will be recruited to the pilot clinical trial.
Detailed description
Within the scope of the study the aims will be to: (1. Develop the pre-implantation assessment protocol utilizing targeted CT to locate optimal gluteal motor points bilaterally.) CT assessment of the pelvic region in spinal cord injured subjects will be carried out to determine regional vascular and nervous anatomy. This will allow us to achieve optimal electrode placement using a minimally invasive implantation procedure. (2. Develop the implanted gluteal stimulation system.) The fully implanted gluteal stimulation (GSTIM) system is envisioned as a marriage between the established technology of the implanted IM electrodes developed by the Cleveland FES Center and the newly developed Micropulse I 2-channel stimulator. The Micropulse I IPG is a small, rechargeable stimulator developed by NDI Medical as a platform technology for neuromodulation and neurostimulation applications. The device will be customized in order to provide two synchronized channels of stimulation for the GSTIM system. (3. Implement and evaluate implanted gluteal stimulation system in human volunteers.) A pilot clinical trial of the fully implanted gluteal stimulation system will be carried out using a two-arm crossover study of ten wheelchair users at risk for pressure ulcer development due to impaired mobility. Pre-defined selection criteria will be employed to screen potential participants physically and psychologically. All participants will receive a stimulation system consisting of implanted IM electrodes inserted bilaterally in the gluteus maximus together with the Micropulse I stimulator implanted subcutaneously in the lower abdomen. Tissue health will be assessed at three month intervals during the 12-month period following implantation. The clinical application of this system is of great relevance to the veteran population at risk of pressure ulcer development. The project will add value to the continued improvement in health care provision for veterans, allowing them to benefit from the most recent advances in medical device technology. Although the initial target user group is veterans with SCI, the proposes system will have applications to other patient populations at risk due to reduced mobility, such as those with multiple sclerosis and the elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: A fully implanted gluteal stimulation (GSTIM) system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Motor and sensory complete SCI higher than the level T12.
Key exclusion criteria (8 listed)
- Eligible subjects will have had no open skin problems or hospitalizations during the three months prior to entrance into the study. Additional exclusion criteria relating to clinical factors and suitability include:
- 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, compromised renal function, diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A fully implanted gluteal stimulation (GSTIM) systemA fully implanted gluteal stimulation system | Device | Arm 1 |
Primary outcome
The primary outcomes measures will be changes in tissue health variables and user satisfaction
Time frame: baseline, 4 weeks, and six months
2 secondary outcomes
Progressive changes in muscle bulk and tissue blood flow will be evaluated using CT scanning and transcutaneous oxygen measurement
Time frame: baseline, 4 weeks, and six months
Pressure distribution changes over the long-term (due to muscle changes) and over the short-term (due to muscle contractions) will be assessed by interface pressure measurement.
Time frame: baseline, 4 weeks, and six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kath M. Bogie, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A fully implanted gluteal stimulation (GSTIM) system in people with Pressure Ulcers, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes measures will be changes in tissue health variables and user satisfaction (time frame: baseline, 4 weeks, and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015; AzTrials last refreshed its copy on 27 Oct 2026.