SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study (SENSE)

April 11, 2016 updated by: Abbott Medical Devices

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain

The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.

Study Overview

Status

Status

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

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.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

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
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • The Pain Center of Arizona
      • Scottsdale, Arizona, United States, 85254
        • Valley Pain Consultants - N. Scottsdale
      • Scottsdale, Arizona, United States, 85255
        • Arizona Pain Specialists
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • The Mocek Spine Clinic
    • California
      • Campbell, California, United States, 95008
        • Comprehensive Pain Management Center
      • Carlsbad, California, United States, 92009
        • Coastal Pain & Spinal Diagnostics Medical Group
      • Oceanside, California, United States, 92056
        • Pacific Pain Medicine Consultants
      • Pasadena, California, United States, 91105
        • Pasadena Rehabilitation Institute
      • Whittier, California, United States, 90602
        • Bright Health Physicians of PIH
    • Colorado
      • Broomfield, Colorado, United States, 80020
        • Comprehensive Pain Specialists
    • Florida
      • Fort Lauderdale, Florida, United States, 33301
        • Holy Cross Orthopedics
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer and Research Institute
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Pain Care LLC
    • Indiana
      • Muncie, Indiana, United States, 47302
        • Interventional Pain Care
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Bluegrass Pain
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Mid Atlantic Spine and Pain Physicians
    • Michigan
      • Brighton, Michigan, United States, 48114
        • Michigan Pain Specialists
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Comprehensive Pain & Rehabilitation
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Lake Success, New York, United States, 11042
        • Neurological Surgery, P.C.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Carolina Pain Institute
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Integrated Pain Solutions
      • Dayton, Ohio, United States, 45417
        • Pain and Spine Center
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19403
        • Performance Spine and Sports Physicians, P.C.
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Vertex Spine and Pain
    • Utah
      • West Jordan, Utah, United States, 84088
        • Granger Pain and Spine
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • The Center for Pain Relief

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

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Subject is 22 years of age or older
  • Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
  • Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
  • Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
  • Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
  • Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)

Key Exclusion Criteria:

  • Subject currently participating in a clinical investigation that includes an active treatment arm
  • Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
  • Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
  • Subject with an infusion pump or any implantable neurostimulator device
  • Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
  • Subject has an existing medical condition that is likely to require the use of diathermy in the future
  • Subject has peripheral vascular disease
  • Subject is immunocompromised
  • Subject has documented history of allergic response to titanium or silicone
  • Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
  • Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: SCS and PNfS
Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field
Device: SCS and PNfS
Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
Other Names:
  • Eon or Eon Mini IPG neurostimulation system with associated components
Active Comparator: SCS Alone
Eon or Eon Mini IPG with epidural leads in the spinal column
Device: SCS Alone
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
Other Names:
  • Eon or Eon Mini IPG neurostimulation system with associated components

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
Measure Description
Time Frame
Safety
Time Frame: 6 months
Evaluation of device or procedure related adverse events
6 months
Efficacy
Time Frame: 3 months
Responder rate in SCS-PNfS vs SCS alone
3 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
Quality of Life
Time Frame: 3 months
3 months
Functional Disability
Time Frame: 3 months
3 months
Worst pain
Time Frame: 3 months
3 months
Rescue medication usage
Time Frame: 3 months
3 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.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Porter McRoberts, MD, Holy Cross Orthopedic Institute

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.
November 1, 2013

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.
February 1, 2016

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.
February 1, 2016

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).
November 15, 2013

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.
November 15, 2013

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.
November 21, 2013

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.
April 13, 2016

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.
April 11, 2016

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.
April 1, 2016

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.
  • C-11-12

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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