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SLUHN 2015-65

A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Ghada Suleiman, RN

  • Synopsis: Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study. The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

    • Candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
    • Willing and able to provide a signed and dated informed consent
    • At least 18 years old at the time of informed consent
    • Willing and able to attend visits and comply with the study protocol
    • Capable of using the patient programmer and recharging the neurostimulator
    • Willing to not increase in pain medications from baseline through the 3-Month Visit

    Subjects meeting the Screening Inclusion/Exclusion criteria will complete the baseline diary, 1 week prior to the Baseline visit (a minimum of 5 days is required). Inclusion criteria that will be confirmed after the baseline diary period include:

    • Baseline diary completed for a minimum of 5 days
    • Baseline diary-reported average NPRS is ≥ 5 for overall pain
    • Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results
    • Based on the medical opinion of the Principal Investigator, Sub-Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), or other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of significant pain medications) that would preclude his/her enrollment in the study or potentially confound the results of the study
    • Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
    • Unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
    • Implanted with a cardiac device (e.g., pacemaker, defibrillator)