None listed
Conditions
Brief summary
The purpose of this study is to determine the safety and device performance of the Spinal Modulation Neurostimulation System in the treatment of chronic pain.
Interventions
This intervention involves the placement of epidural leads that provide stimulation. Stimulation intensity and the amount of of stimulation during the day is controlled by the subject to the desired levels during the duration of the clinical trial. The mechanism of action is unknown. Subject will be followed up for 12 months following implantation neurostimulator system. Trial duration is expected to be approximately 15-18 months.
Sponsors
Spinal Modulation
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Male or female >= 18 years old 2) Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months 3) Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain 4) Minimum baseline pain rating of 60 mm on the VAS 5) Stable pain medication dosage for at least 30 days 6) Stable neurologic function in the past 30 days
Exclusion criteria
1) Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control 2) Escalating or changing pain condition within the past month as evidenced by investigator examination 3) Subject is currently involved in medically related litigation 4) Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump 5) Subject currently has an active infection 6) Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device 7) Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 8) Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement
Outcome results
None listed