Implanted Gluteal Stimulation System for Pressure Sore Prevention

May 21, 2015 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Motor and sensory complete SCI higher than the level T12.

Exclusion Criteria:

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:

  1. Age less than 18 years.
  2. Less than two years post-injury or loss of independent walking ability.
  3. More than three urinary tract infections in the previous year.
  4. Significant active systemic disease, e.g. heart disease, renal failure, compromised renal function, diabetes.
  5. Abnormal nutritional status based on albumin and total protein levels at recruitment (3.0 for albumin, 6.0 for total protein).
  6. Osteomyelitis of the pelvic regional, indicated by positive pelvic inlet x-ray from routine annual urologic examination or bone scan.
  7. Previous surgery in the perineal region that radically alters the basic anatomy, particularly regional innervation and blood supply., e.g., amputation, hemipelvectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Arm 1
Device: A fully implanted gluteal stimulation (GSTIM) system
A fully implanted gluteal stimulation system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary outcomes measures will be changes in tissue health variables and user satisfaction
Time Frame: baseline, 4 weeks, and six months
baseline, 4 weeks, and six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
baseline, 4 weeks, and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
US Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B4664-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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