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Trial record 1 of 1 for:    NCT01990287
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SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study (SENSE)

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ClinicalTrials.gov Identifier: NCT01990287
Recruitment Status : Terminated (Sponsor decision)
First Posted : November 21, 2013
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Post-Laminectomy Syndrome Low Back Pain Device: SCS and PNfS Device: SCS Alone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
Study Start Date : November 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
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 Name: 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 Name: Eon or Eon Mini IPG neurostimulation system with associated components




Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]
    Evaluation of device or procedure related adverse events

  2. Efficacy [ Time Frame: 3 months ]
    Responder rate in SCS-PNfS vs SCS alone


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 3 months ]
  2. Functional Disability [ Time Frame: 3 months ]
  3. Worst pain [ Time Frame: 3 months ]
  4. Rescue medication usage [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT01990287


  Show 28 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Principal Investigator: Porter McRoberts, MD Holy Cross Orthopedic Institute

Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01990287     History of Changes
Other Study ID Numbers: C-11-12
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Abbott Medical Devices:
Low Back Pain
Failed Back surgery Syndrome
Post-Laminectomy Syndrome
Spinal Cord Stimulation
Peripheral Nerve field Stimulation
Pain

Additional relevant MeSH terms:
Syndrome
Back Pain
Low Back Pain
Failed Back Surgery Syndrome
Postoperative Complications
Spinal Diseases
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases